Otsuka America Pharmaceutical Inc.

Otsuka America Pharmaceutical Inc. is seeking a Regulatory Compliance role in Boise, Idaho, responsible for ensuring promotional materials align with laws and regulations. This position requires 6+ years in pharmaceutical compliance, regulatory guidance, and strong collaboration skills across multiple teams. The role offers an attractive pay range from $186,489.00 to $278,875.00, with comprehensive benefits that include health coverage, 401(k) matching, and flexible time off.

Analyzes and interprets new regulations and Guidance to Industry documents, and monitors the impact of Office of Prescription Drug Promotion (OPDP) correspondence and enforcement actions.Reviews and approves promotional materials and provides strategic guidance on promotional messaging.Provides strategic regulatory guidance during pre-launch and launch activities, including review of promotional claims, scientific communications, disease state education materials, and disease awareness initiatives.Reviews promotional materials and communications to ensure consistency with approved product labeling, regulatory requirements, and appropriateness for the intended audience and use.Partners cross-functionally with Commercial, Medical, Legal, and Regulatory teams to support launch activities and promotional strategy.Responsible for final review and approval of promotional materials, sales training materials, and corporate communications.Supports review of materials related to complex or highly specialized disease states, including diagnostic or testing considerations, patient identification, and disease education.Ensures product promotional materials are submitted to OPDP on FDA Form 2253 in a timely manner and archived as per company policy.Monitors changes in U.S. promotional regulations and corporate policies and procedures, and incorporates those changes into departmental processes, as appropriate.Participates in cross-functional meetings and teams, including the Global Regulatory Team (GRT) and Global Labeling Team (GLT).Participates in launch planning and cross-functional discussions for pipeline and commercialization activities.Provides training to internal employees and affiliates on promotional compliance regulations, as appropriate.Acts as a liaison between the company and OPDP and supports regulatory discussions related to promotional strategy, as appropriate.Required Qualifications 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotechnology or pharmaceutical industryExperience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activitiesExperience supporting rare disease productsDemonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environmentsDemonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environmentSolid understanding of U.S. regulatory requirementsExcellent understanding of medical concepts and terminologyStrong understanding of FDA advertising and promotion requirements and applicable product labelingFundamental understanding of the pharmaceutical industry drug development processPreferred Qualifications Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Otsuka is an equal opportunity employer. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.

In this role, you will play a crucial part in analyzing new regulations, reviewing promotional messaging, and guiding our promotional strategies. Key Responsibilities: Review and approve promotional materials to ensure compliance and alignment with approved product labeling and regulatory requirements.Provide strategic regulatory guidance during pre-launch and launch activities, ensuring all messaging is scientifically sound and appropriately targeted.Collaborate with cross-functional teams including Commercial, Medical, Legal, and Regulatory to support promotional strategies and product launches.Act as a key liaison with the Office of Prescription Drug Promotion (OPDP) on promotional strategy discussions and submissions.Monitor changes in U.S. promotional regulations, integrating updates into departmental processes.Conduct training sessions for internal teams regarding promotional compliance regulations.Required Qualifications: 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotech or pharmaceutical industry.Hands-on experience supporting pharmaceutical product launches, including pre-launch and commercialization activities.Solid understanding of U.S. regulatory requirements related to advertising and promotion.Strong capabilities for providing practical and risk-based regulatory guidance.Excellent written and verbal communication skills.Preferred Qualifications: Accommodation of Disability: If you are a qualified individual with a disability, you may request a reasonable accommodation to apply for this position.

In this role, you will play a crucial part in analyzing new regulations, reviewing promotional messaging, and guiding our promotional strategies. Key Responsibilities: Review and approve promotional materials to ensure compliance and alignment with approved product labeling and regulatory requirements.Provide strategic regulatory guidance during pre-launch and launch activities, ensuring all messaging is scientifically sound and appropriately targeted.Collaborate with cross-functional teams including Commercial, Medical, Legal, and Regulatory to support promotional strategies and product launches.Act as a key liaison with the Office of Prescription Drug Promotion (OPDP) on promotional strategy discussions and submissions.Monitor changes in U.S. promotional regulations, integrating updates into departmental processes.Conduct training sessions for internal teams regarding promotional compliance regulations.Required Qualifications: 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotech or pharmaceutical industry.Hands-on experience supporting pharmaceutical product launches, including pre-launch and commercialization activities.Solid understanding of U.S. regulatory requirements related to advertising and promotion.Strong capabilities for providing practical and risk-based regulatory guidance.Excellent written and verbal communication skills.Preferred Qualifications: Accommodation of Disability: If you are a qualified individual with a disability, you may request a reasonable accommodation to apply for this position.

In this role, you will play a crucial part in analyzing new regulations, reviewing promotional messaging, and guiding our promotional strategies. Key Responsibilities: Review and approve promotional materials to ensure compliance and alignment with approved product labeling and regulatory requirements.Provide strategic regulatory guidance during pre-launch and launch activities, ensuring all messaging is scientifically sound and appropriately targeted.Collaborate with cross-functional teams including Commercial, Medical, Legal, and Regulatory to support promotional strategies and product launches.Act as a key liaison with the Office of Prescription Drug Promotion (OPDP) on promotional strategy discussions and submissions.Monitor changes in U.S. promotional regulations, integrating updates into departmental processes.Conduct training sessions for internal teams regarding promotional compliance regulations.Required Qualifications: 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotech or pharmaceutical industry.Hands-on experience supporting pharmaceutical product launches, including pre-launch and commercialization activities.Solid understanding of U.S. regulatory requirements related to advertising and promotion.Strong capabilities for providing practical and risk-based regulatory guidance.Excellent written and verbal communication skills.Preferred Qualifications: Accommodation of Disability: If you are a qualified individual with a disability, you may request a reasonable accommodation to apply for this position.

In this role, you will play a crucial part in analyzing new regulations, reviewing promotional messaging, and guiding our promotional strategies. Key Responsibilities: Review and approve promotional materials to ensure compliance and alignment with approved product labeling and regulatory requirements.Provide strategic regulatory guidance during pre-launch and launch activities, ensuring all messaging is scientifically sound and appropriately targeted.Collaborate with cross-functional teams including Commercial, Medical, Legal, and Regulatory to support promotional strategies and product launches.Act as a key liaison with the Office of Prescription Drug Promotion (OPDP) on promotional strategy discussions and submissions.Monitor changes in U.S. promotional regulations, integrating updates into departmental processes.Conduct training sessions for internal teams regarding promotional compliance regulations.Required Qualifications: 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotech or pharmaceutical industry.Hands-on experience supporting pharmaceutical product launches, including pre-launch and commercialization activities.Solid understanding of U.S. regulatory requirements related to advertising and promotion.Strong capabilities for providing practical and risk-based regulatory guidance.Excellent written and verbal communication skills.Preferred Qualifications: Accommodation of Disability: If you are a qualified individual with a disability, you may request a reasonable accommodation to apply for this position.

In this role, you will play a crucial part in analyzing new regulations, reviewing promotional messaging, and guiding our promotional strategies. Key Responsibilities: Review and approve promotional materials to ensure compliance and alignment with approved product labeling and regulatory requirements.Provide strategic regulatory guidance during pre-launch and launch activities, ensuring all messaging is scientifically sound and appropriately targeted.Collaborate with cross-functional teams including Commercial, Medical, Legal, and Regulatory to support promotional strategies and product launches.Act as a key liaison with the Office of Prescription Drug Promotion (OPDP) on promotional strategy discussions and submissions.Monitor changes in U.S. promotional regulations, integrating updates into departmental processes.Conduct training sessions for internal teams regarding promotional compliance regulations.Required Qualifications: 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotech or pharmaceutical industry.Hands-on experience supporting pharmaceutical product launches, including pre-launch and commercialization activities.Solid understanding of U.S. regulatory requirements related to advertising and promotion.Strong capabilities for providing practical and risk-based regulatory guidance.Excellent written and verbal communication skills.Preferred Qualifications: Accommodation of Disability: If you are a qualified individual with a disability, you may request a reasonable accommodation to apply for this position.

In this role, you will play a crucial part in analyzing new regulations, reviewing promotional messaging, and guiding our promotional strategies. Key Responsibilities: Review and approve promotional materials to ensure compliance and alignment with approved product labeling and regulatory requirements.Provide strategic regulatory guidance during pre-launch and launch activities, ensuring all messaging is scientifically sound and appropriately targeted.Collaborate with cross-functional teams including Commercial, Medical, Legal, and Regulatory to support promotional strategies and product launches.Act as a key liaison with the Office of Prescription Drug Promotion (OPDP) on promotional strategy discussions and submissions.Monitor changes in U.S. promotional regulations, integrating updates into departmental processes.Conduct training sessions for internal teams regarding promotional compliance regulations.Required Qualifications: 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotech or pharmaceutical industry.Hands-on experience supporting pharmaceutical product launches, including pre-launch and commercialization activities.Solid understanding of U.S. regulatory requirements related to advertising and promotion.Strong capabilities for providing practical and risk-based regulatory guidance.Excellent written and verbal communication skills.Preferred Qualifications: Accommodation of Disability: If you are a qualified individual with a disability, you may request a reasonable accommodation to apply for this position.

As the Director of Advertising and Promotion Strategy, you will lead our efforts in reviewing, approving, and strategizing promotional materials and communications for prescription drugs and medical devices. Key Responsibilities: Ensure promotional materials and communications adhere to legal, regulatory, and company requirements while analyzing new regulations and Guidance to Industry documents.Review and approve promotional materials and provide strategic advice on effective messaging.Offer regulatory guidance during pre-launch and launch phases, including the evaluation of promotional claims and medical communications.Confirm promotional consistency with approved product labeling and appropriateness for the target audience.Collaborate with Commercial, Medical, Legal, and Regulatory teams to enhance promotional strategies and support launch activities.Conduct final reviews and approvals for promotional materials, sales training content, and corporate communications.Support the review of materials related to specialized disease states and patient education.Ensure all promotional materials are submitted to OPDP timely using FDA Form 2253 and archived according to company policy.Track changes in promotional regulations and corporate policies, integrating updates as necessary.Engage in cross-functional meetings, contributing to Global Regulatory Team (GRT) and Global Labeling Team (GLT) discussions.Participate in the planning and collaborative discussions for pipeline commercialization activities.Provide training to internal staff and affiliates on compliance with promotional regulations.Act as a liaison with OPDP, facilitating discussions on promotional strategies.Qualifications: Required: 6+ years of experience in pharmaceutical advertising and promotion compliance.Proven track record in leading or supporting pharmaceutical product launches, particularly in rare diseases.Ability to provide practical, risk-based regulatory guidance in cross-functional environments.Proficient understanding of U.S. regulatory requirements, medical terminology, and FDA advertising standards.Solid grasp of pharmaceutical industry drug development processes.Preferred:

As the Director of Advertising and Promotion Strategy, you will lead our efforts in reviewing, approving, and strategizing promotional materials and communications for prescription drugs and medical devices. Key Responsibilities: Ensure promotional materials and communications adhere to legal, regulatory, and company requirements while analyzing new regulations and Guidance to Industry documents.Review and approve promotional materials and provide strategic advice on effective messaging.Offer regulatory guidance during pre-launch and launch phases, including the evaluation of promotional claims and medical communications.Confirm promotional consistency with approved product labeling and appropriateness for the target audience.Collaborate with Commercial, Medical, Legal, and Regulatory teams to enhance promotional strategies and support launch activities.Conduct final reviews and approvals for promotional materials, sales training content, and corporate communications.Support the review of materials related to specialized disease states and patient education.Ensure all promotional materials are submitted to OPDP timely using FDA Form 2253 and archived according to company policy.Track changes in promotional regulations and corporate policies, integrating updates as necessary.Engage in cross-functional meetings, contributing to Global Regulatory Team (GRT) and Global Labeling Team (GLT) discussions.Participate in the planning and collaborative discussions for pipeline commercialization activities.Provide training to internal staff and affiliates on compliance with promotional regulations.Act as a liaison with OPDP, facilitating discussions on promotional strategies.Qualifications: Required: 6+ years of experience in pharmaceutical advertising and promotion compliance.Proven track record in leading or supporting pharmaceutical product launches, particularly in rare diseases.Ability to provide practical, risk-based regulatory guidance in cross-functional environments.Proficient understanding of U.S. regulatory requirements, medical terminology, and FDA advertising standards.Solid grasp of pharmaceutical industry drug development processes.Preferred:

Otsuka America Pharmaceutical Inc. is looking for a Regulatory Compliance Manager in Honolulu, Hawaii. The role involves ensuring that promotional materials meet all legal and regulatory requirements. You will provide guidance for promotional strategies and collaborate with various internal teams. Ideal candidates should have over 6 years of experience in pharmaceutical compliance and a solid understanding of U.S. regulations. The position offers comprehensive benefits and a competitive salary ranging from $186,489 to $278,875.

Otsuka America Pharmaceutical Inc. in Austin, Texas, is seeking a Regulatory Compliance Leader with over 6 years of experience in pharmaceutical advertising and promotion compliance. This role is essential in ensuring that all promotional materials meet regulatory standards and provides strategic guidance during product launches. The ideal candidate must possess strong strategic thinking skills, a solid understanding of U.S. regulatory requirements, and demonstrate the ability to collaborate effectively across multifunctional teams. The position offers comprehensive benefits and a competitive salary range. #J-18808-Ljbffr

Otsuka America Pharmaceutical Inc. seeks an experienced professional to ensure compliance of promotional materials with regulations. This role involves working cross-functionally during product launches, providing strategic regulatory guidance and monitoring compliance with FDA requirements. The ideal candidate will have 6+ years in pharmaceutical advertising and promotion, strong communication skills, and a Bachelor's degree, with advanced degrees preferred. Comprehensive benefits include medical coverage, tuition reimbursement, and a generous 401(k) match. #J-18808-Ljbffr

Ensures that promotional and training materials meet applicable regulatory and company requirements. The candidate must demonstrate a strong understanding of advertising and promotion regulatory requirements and serve as a strategic regulatory partner supporting rare disease launch and commercialization activities. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.

Ensures that promotional and training materials meet applicable regulatory and company requirements. The candidate must demonstrate a strong understanding of advertising and promotion regulatory requirements and serve as a strategic regulatory partner supporting rare disease launch and commercialization activities. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.

Ensures that promotional and training materials meet applicable regulatory and company requirements. The candidate must demonstrate a strong understanding of advertising and promotion regulatory requirements and serve as a strategic regulatory partner supporting rare disease launch and commercialization activities. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.

Otsuka America Pharmaceutical Inc. is looking for a Regulatory Compliance Manager in Little Rock, Arkansas. This position requires over 6 years of experience in pharmaceutical advertising compliance and involves ensuring promotional materials meet regulatory standards. The ideal candidate will provide strategic guidance during product launches and work cross-functionally with commercial and medical teams. A Bachelor's degree is required, with advanced degrees preferred. Benefits include comprehensive medical coverage, 401(k) match, and flexible time off.

Ensures that promotional and training materials meet applicable regulatory and company requirements. The candidate must demonstrate a strong understanding of advertising and promotion regulatory requirements and serve as a strategic regulatory partner supporting rare disease launch and commercialization activities. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.

+ Acts as a liaison between the company and OPDP and supports regulatory discussions related to promotional strategy, as appropriate. **Qualifications** **Required:** + 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotechnology or pharmaceutical industry + Experience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activities + Experience supporting rare disease products + Demonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environments + Demonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environment + Solid understanding of U.S. regulatory requirements + Excellent understanding of medical concepts and terminology + Strong understanding of FDA advertising and promotion requirements and applicable product labeling + Fundamental understanding of the pharmaceutical industry drug development process **Preferred:** + 8+ years of experience supporting pharmaceutical advertising and promotion compliance activities + Experience supporting neurology or other specialty therapeutic areas preferred + Experience interacting with OPDP in support of launch programs preferred + Experience supporting investigational or accelerated approval products preferred + Experience leading, mentoring, or developing promotion compliance team members and influencing cross-functional stakeholders + Able to work across multifunctional groups + Strong written and oral communication skills + Strong computer skills including experience with MS Office: Word, Excel, PowerPoint, Veeva PromoMats, CREDO, Outlook, Teams, and Adobe Acrobat + The ideal candidate should demonstrate strong judgment, accountability, and the ability to work effectively across multifunctional teams. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property.

+ Acts as a liaison between the company and OPDP and supports regulatory discussions related to promotional strategy, as appropriate. **Qualifications** **Required:** + 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotechnology or pharmaceutical industry + Experience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activities + Experience supporting rare disease products + Demonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environments + Demonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environment + Solid understanding of U.S. regulatory requirements + Excellent understanding of medical concepts and terminology + Strong understanding of FDA advertising and promotion requirements and applicable product labeling + Fundamental understanding of the pharmaceutical industry drug development process **Preferred:** + 8+ years of experience supporting pharmaceutical advertising and promotion compliance activities + Experience supporting neurology or other specialty therapeutic areas preferred + Experience interacting with OPDP in support of launch programs preferred + Experience supporting investigational or accelerated approval products preferred + Experience leading, mentoring, or developing promotion compliance team members and influencing cross-functional stakeholders + Able to work across multifunctional groups + Strong written and oral communication skills + Strong computer skills including experience with MS Office: Word, Excel, PowerPoint, Veeva PromoMats, CREDO, Outlook, Teams, and Adobe Acrobat + The ideal candidate should demonstrate strong judgment, accountability, and the ability to work effectively across multifunctional teams. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property.

+ Acts as a liaison between the company and OPDP and supports regulatory discussions related to promotional strategy, as appropriate. **Qualifications** **Required:** + 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotechnology or pharmaceutical industry + Experience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activities + Experience supporting rare disease products + Demonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environments + Demonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environment + Solid understanding of U.S. regulatory requirements + Excellent understanding of medical concepts and terminology + Strong understanding of FDA advertising and promotion requirements and applicable product labeling + Fundamental understanding of the pharmaceutical industry drug development process **Preferred:** + 8+ years of experience supporting pharmaceutical advertising and promotion compliance activities + Experience supporting neurology or other specialty therapeutic areas preferred + Experience interacting with OPDP in support of launch programs preferred + Experience supporting investigational or accelerated approval products preferred + Experience leading, mentoring, or developing promotion compliance team members and influencing cross-functional stakeholders + Able to work across multifunctional groups + Strong written and oral communication skills + Strong computer skills including experience with MS Office: Word, Excel, PowerPoint, Veeva PromoMats, CREDO, Outlook, Teams, and Adobe Acrobat + The ideal candidate should demonstrate strong judgment, accountability, and the ability to work effectively across multifunctional teams. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property.

+ Acts as a liaison between the company and OPDP and supports regulatory discussions related to promotional strategy, as appropriate. **Qualifications** **Required:** + 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotechnology or pharmaceutical industry + Experience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activities + Experience supporting rare disease products + Demonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environments + Demonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environment + Solid understanding of U.S. regulatory requirements + Excellent understanding of medical concepts and terminology + Strong understanding of FDA advertising and promotion requirements and applicable product labeling + Fundamental understanding of the pharmaceutical industry drug development process **Preferred:** + 8+ years of experience supporting pharmaceutical advertising and promotion compliance activities + Experience supporting neurology or other specialty therapeutic areas preferred + Experience interacting with OPDP in support of launch programs preferred + Experience supporting investigational or accelerated approval products preferred + Experience leading, mentoring, or developing promotion compliance team members and influencing cross-functional stakeholders + Able to work across multifunctional groups + Strong written and oral communication skills + Strong computer skills including experience with MS Office: Word, Excel, PowerPoint, Veeva PromoMats, CREDO, Outlook, Teams, and Adobe Acrobat + The ideal candidate should demonstrate strong judgment, accountability, and the ability to work effectively across multifunctional teams. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property.

+ Acts as a liaison between the company and OPDP and supports regulatory discussions related to promotional strategy, as appropriate. **Qualifications** **Required:** + 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotechnology or pharmaceutical industry + Experience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activities + Experience supporting rare disease products + Demonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environments + Demonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environment + Solid understanding of U.S. regulatory requirements + Excellent understanding of medical concepts and terminology + Strong understanding of FDA advertising and promotion requirements and applicable product labeling + Fundamental understanding of the pharmaceutical industry drug development process **Preferred:** + 8+ years of experience supporting pharmaceutical advertising and promotion compliance activities + Experience supporting neurology or other specialty therapeutic areas preferred + Experience interacting with OPDP in support of launch programs preferred + Experience supporting investigational or accelerated approval products preferred + Experience leading, mentoring, or developing promotion compliance team members and influencing cross-functional stakeholders + Able to work across multifunctional groups + Strong written and oral communication skills + Strong computer skills including experience with MS Office: Word, Excel, PowerPoint, Veeva PromoMats, CREDO, Outlook, Teams, and Adobe Acrobat + The ideal candidate should demonstrate strong judgment, accountability, and the ability to work effectively across multifunctional teams. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property.

+ Acts as a liaison between the company and OPDP and supports regulatory discussions related to promotional strategy, as appropriate. **Qualifications** **Required:** + 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotechnology or pharmaceutical industry + Experience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activities + Experience supporting rare disease products + Demonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environments + Demonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environment + Solid understanding of U.S. regulatory requirements + Excellent understanding of medical concepts and terminology + Strong understanding of FDA advertising and promotion requirements and applicable product labeling + Fundamental understanding of the pharmaceutical industry drug development process **Preferred:** + 8+ years of experience supporting pharmaceutical advertising and promotion compliance activities + Experience supporting neurology or other specialty therapeutic areas preferred + Experience interacting with OPDP in support of launch programs preferred + Experience supporting investigational or accelerated approval products preferred + Experience leading, mentoring, or developing promotion compliance team members and influencing cross-functional stakeholders + Able to work across multifunctional groups + Strong written and oral communication skills + Strong computer skills including experience with MS Office: Word, Excel, PowerPoint, Veeva PromoMats, CREDO, Outlook, Teams, and Adobe Acrobat + The ideal candidate should demonstrate strong judgment, accountability, and the ability to work effectively across multifunctional teams. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property.

+ Acts as a liaison between the company and OPDP and supports regulatory discussions related to promotional strategy, as appropriate. **Qualifications** **Required:** + 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotechnology or pharmaceutical industry + Experience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activities + Experience supporting rare disease products + Demonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environments + Demonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environment + Solid understanding of U.S. regulatory requirements + Excellent understanding of medical concepts and terminology + Strong understanding of FDA advertising and promotion requirements and applicable product labeling + Fundamental understanding of the pharmaceutical industry drug development process **Preferred:** + 8+ years of experience supporting pharmaceutical advertising and promotion compliance activities + Experience supporting neurology or other specialty therapeutic areas preferred + Experience interacting with OPDP in support of launch programs preferred + Experience supporting investigational or accelerated approval products preferred + Experience leading, mentoring, or developing promotion compliance team members and influencing cross-functional stakeholders + Able to work across multifunctional groups + Strong written and oral communication skills + Strong computer skills including experience with MS Office: Word, Excel, PowerPoint, Veeva PromoMats, CREDO, Outlook, Teams, and Adobe Acrobat + The ideal candidate should demonstrate strong judgment, accountability, and the ability to work effectively across multifunctional teams. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property.

+ Acts as a liaison between the company and OPDP and supports regulatory discussions related to promotional strategy, as appropriate. **Qualifications** **Required:** + 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotechnology or pharmaceutical industry + Experience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activities + Experience supporting rare disease products + Demonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environments + Demonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environment + Solid understanding of U.S. regulatory requirements + Excellent understanding of medical concepts and terminology + Strong understanding of FDA advertising and promotion requirements and applicable product labeling + Fundamental understanding of the pharmaceutical industry drug development process **Preferred:** + 8+ years of experience supporting pharmaceutical advertising and promotion compliance activities + Experience supporting neurology or other specialty therapeutic areas preferred + Experience interacting with OPDP in support of launch programs preferred + Experience supporting investigational or accelerated approval products preferred + Experience leading, mentoring, or developing promotion compliance team members and influencing cross-functional stakeholders + Able to work across multifunctional groups + Strong written and oral communication skills + Strong computer skills including experience with MS Office: Word, Excel, PowerPoint, Veeva PromoMats, CREDO, Outlook, Teams, and Adobe Acrobat + The ideal candidate should demonstrate strong judgment, accountability, and the ability to work effectively across multifunctional teams. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property.

Ensures that promotional and training materials meet applicable regulatory and company requirements. The candidate must demonstrate a strong understanding of advertising and promotion regulatory requirements and serve as a strategic regulatory partner supporting rare disease launch and commercialization activities. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.

+ Acts as a liaison between the company and OPDP and supports regulatory discussions related to promotional strategy, as appropriate. **Qualifications** **Required:** + 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotechnology or pharmaceutical industry + Experience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activities + Experience supporting rare disease products + Demonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environments + Demonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environment + Solid understanding of U.S. regulatory requirements + Excellent understanding of medical concepts and terminology + Strong understanding of FDA advertising and promotion requirements and applicable product labeling + Fundamental understanding of the pharmaceutical industry drug development process **Preferred:** + 8+ years of experience supporting pharmaceutical advertising and promotion compliance activities + Experience supporting neurology or other specialty therapeutic areas preferred + Experience interacting with OPDP in support of launch programs preferred + Experience supporting investigational or accelerated approval products preferred + Experience leading, mentoring, or developing promotion compliance team members and influencing cross-functional stakeholders + Able to work across multifunctional groups + Strong written and oral communication skills + Strong computer skills including experience with MS Office: Word, Excel, PowerPoint, Veeva PromoMats, CREDO, Outlook, Teams, and Adobe Acrobat + The ideal candidate should demonstrate strong judgment, accountability, and the ability to work effectively across multifunctional teams. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property.

+ Acts as a liaison between the company and OPDP and supports regulatory discussions related to promotional strategy, as appropriate. **Qualifications** **Required:** + 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotechnology or pharmaceutical industry + Experience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activities + Experience supporting rare disease products + Demonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environments + Demonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environment + Solid understanding of U.S. regulatory requirements + Excellent understanding of medical concepts and terminology + Strong understanding of FDA advertising and promotion requirements and applicable product labeling + Fundamental understanding of the pharmaceutical industry drug development process **Preferred:** + 8+ years of experience supporting pharmaceutical advertising and promotion compliance activities + Experience supporting neurology or other specialty therapeutic areas preferred + Experience interacting with OPDP in support of launch programs preferred + Experience supporting investigational or accelerated approval products preferred + Experience leading, mentoring, or developing promotion compliance team members and influencing cross-functional stakeholders + Able to work across multifunctional groups + Strong written and oral communication skills + Strong computer skills including experience with MS Office: Word, Excel, PowerPoint, Veeva PromoMats, CREDO, Outlook, Teams, and Adobe Acrobat + The ideal candidate should demonstrate strong judgment, accountability, and the ability to work effectively across multifunctional teams. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property.

Ensures that promotional and training materials meet applicable regulatory and company requirements. The candidate must demonstrate a strong understanding of advertising and promotion regulatory requirements and serve as a strategic regulatory partner supporting rare disease launch and commercialization activities. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.

Ensures that promotional and training materials meet applicable regulatory and company requirements. The candidate must demonstrate a strong understanding of advertising and promotion regulatory requirements and serve as a strategic regulatory partner supporting rare disease launch and commercialization activities. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.

Ensures that promotional and training materials meet applicable regulatory and company requirements. The candidate must demonstrate a strong understanding of advertising and promotion regulatory requirements and serve as a strategic regulatory partner supporting rare disease launch and commercialization activities. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.

Ensures that promotional and training materials meet applicable regulatory and company requirements. The candidate must demonstrate a strong understanding of advertising and promotion regulatory requirements and serve as a strategic regulatory partner supporting rare disease launch and commercialization activities. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.

Ensures that promotional and training materials meet applicable regulatory and company requirements. The candidate must demonstrate a strong understanding of advertising and promotion regulatory requirements and serve as a strategic regulatory partner supporting rare disease launch and commercialization activities. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.

Ensures that promotional and training materials meet applicable regulatory and company requirements. The candidate must demonstrate a strong understanding of advertising and promotion regulatory requirements and serve as a strategic regulatory partner supporting rare disease launch and commercialization activities. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.

Ensures that promotional and training materials meet applicable regulatory and company requirements. The candidate must demonstrate a strong understanding of advertising and promotion regulatory requirements and serve as a strategic regulatory partner supporting rare disease launch and commercialization activities. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.

**Qualifications & Key Competencies** + Bachelor's degree in Business, Marketing, or a related field; MBA preferred + 8+ years of experience in marketing operations, agency management, and/or marketing effectiveness within the pharmaceutical or healthcare industry + Strong project management and process optimization expertise + Experience in agency/vendor relationship management and marketing budget oversight + Ability to analyze marketing performance data and leverage insights for strategic adjustments + Excellent communication, negotiation, and stakeholder management skills + Proven ability to drive cross-functional collaboration and execute process improvements + Experience working in a matrixed environment with multiple stakeholders **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External . All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property.