Parexel

Parexel is seeking a Senior Regulatory Strategist, Advertising & Promotion, to serve as a trusted advisor across Medical Affairs, Legal, Commercial, Marketing, and Clinical teams. This remote role requires independent review of materials, applying FDA guidance, and adapting strategies to evolving enforcement trends to support business goals while mitigating risk. The candidate should bring 7+ years of Regulatory Affairs experience in pharma/biotech/medical devices, with deep knowledge of FDA #J-18808-Ljbffr

This individual will act as a trusted advisor, collaborating across cross-functional teams within a large, dedicated client partnership—helping to influence regulatory strategy and deliver meaningful impact, all while working remotely. This role extends beyond execution, requiring a proactive leader who can independently review materials, interpret evolving FDA guidance, and pivot regulatory strategy to support business objectives while mitigating risk. • Serve as a strategic regulatory partner to cross-functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams • Independently review and approve promotional and non-promotional materials, ensuring compliance with applicable FDA regulations, guidance, and industry standards (e.g., OPDP requirements) • 7+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, with a strong emphasis on Advertising & Promotion

Parexel is seeking a Manager in Regulatory Affairs Advertising & Promotion in Trenton, NJ. This position requires collaboration with cross-functional teams and the ability to influence regulatory strategy while ensuring compliance with FDA regulations. The ideal candidate will have over 7 years of experience in similar roles, acting as a strategic advisor and reviewing promotional materials. This remote role offers high visibility and the opportunity to operate as a strategic leader in a growing partnership. Strong communication and stakeholder management skills are essential.

Parexel is seeking an experienced Manager of Regulatory Affairs Advertising & Promotion to join our remote team in the U.S. This role will influence regulatory strategy and oversee promotional materials for client partnerships.You will collaborate across Medical Affairs, Legal, Commercial, and Clinical teams to ensure compliant, scientifically accurate communications. The ideal candidate has 7+ years in regulatory affairs focused on advertising and promotion, with strong FDA guidance#J-18808-Ljbffr

Parexel is seeking a Manager, Regulatory Affairs Advertising & Promotion in Lansing, Michigan. This role requires a proactive leader to influence regulatory strategy across various teams while working remotely.Key responsibilities include reviewing promotional materials for compliance, providing strategic regulatory guidance, and mentoring junior team members. Ideal candidates should have over 7 years of experience in the pharmaceutical industry.#J-18808-Ljbffr

Parexel is seeking a Manager for Regulatory Affairs Advertising & Promotion who will lead regulatory strategy and compliance efforts. This role requires a strategic leader with extensive experience in the pharmaceutical industry, focusing on FDA regulations. The candidate will work remotely, promoting collaboration across teams while influencing brand strategy and maintaining compliance. The ideal applicant has over 7 years of experience in Regulatory Affairs, particularly in Advertising & Promotion, and excellent stakeholder management skills. #J-18808-Ljbffr

Parexel is seeking a Manager, Regulatory Affairs Advertising & Promotion in Jackson, Mississippi. This role requires 7+ years of experience and involves acting as a strategic regulatory partner across teams to ensure compliance with FDA regulations.The successful candidate will independently review materials, actively interpret FDA guidance, and influence regulatory strategies while mentoring junior team members. This position offers a high-visibility opportunity to directly influence brand strategy within a collaborative environment.#J-18808-Ljbffr

Parexel is seeking a highly strategic and experienced Manager, Regulatory Affairs Advertising & Promotion in Honolulu, Hawaii. This role involves acting as a trusted advisor, collaborating across teams to influence regulatory strategy while ensuring compliance with FDA regulations. The ideal candidate will have over 7 years of experience in Regulatory Affairs, particularly in advertising and promotion, and will be responsible for mentoring junior team members and leading regulatory review committees. #J-18808-Ljbffr

Our client partnerships continue to grow! As a result, we are looking to hire an additional highly strategic and experienced Manager, Advertising & Promotion to join our team. Key Responsibilities - Serve as a strategic regulatory partner to cross-functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams - Act as a trusted subject matter expert (SME) in FDA Advertising & Promotion regulations, providing high-level guidance on complex regulatory scenarios - Independently review and approve promotional and non-promotional materials, ensuring compliance with applicable FDA regulations, guidance, and industry standards (e.g., OPDP requirements) - Proactively interpret and apply FDA guidance, identifying risks and opportunities to inform sound regulatory strategy - Demonstrate the ability to pivot regulatory strategy based on evolving FDA expectations, enforcement trends, and business needs - Provide strategic input early in the development lifecycle, influencing messaging, claims, and communication strategy - Partner with Legal and Medical Affairs to ensure balanced, compliant, and scientifically accurate communications - Lead discussions on risk assessment and mitigation strategies, offering solutions-oriented recommendations - Support and, where needed, lead regulatory review committees (e.g., PRC/MLR), driving efficient and compliant review processes - Stay current with regulatory trends, FDA warning letters, and industry best practices, proactively sharing insights with internal stakeholders - Mentor junior team members and contribute to building organizational regulatory capability Qualifications - 7+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, with a strong emphasis on Advertising & Promotion - Deep and demonstrated knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activities - Proven ability to act as a strategic advisor and trusted partner to senior stakeholders - Extensive experience collaborating with Medical Affairs, Legal, and Commercial teams - Demonstrated ability to independently review promotional materials and make sound regulatory decisions - Strong experience in interpreting and applying FDA guidance to real-world scenarios, including the ability to adapt strategies accordingly - Excellent communication, influence, and stakeholder management skills - Strong critical thinking and problem-solving abilities, with a proactive and solutions-oriented mindset Preferred Qualifications - Experience supporting product launches or high-visibility brands - Familiarity with global regulatory considerations (nice to have) - Prior experience leading or facilitating MLR/PRC committees What Sets This Role Apart - Opportunity to operate as a strategic, enterprise-level regulatory leader - High visibility across commercial and medical leadership teams - Ability to directly influence brand strategy while ensuring compliance and patient safety EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Parexel is in search of a Senior Regulatory Consultant specializing in Advertising & Promotion in Providence, Rhode Island. The successful candidate will serve as a strategic advisor across various teams, ensuring compliance with FDA regulations. This role requires a proactive leader with extensive experience in Regulatory Affairs, especially within the pharmaceutical industry. Candidates should possess strong communication skills and the ability to influence brand strategy while promoting compliance and safety.

We are seeking a highly strategic and experienced Senior Regulatory Consultant – Advertising & Promotion to serve as a trusted advisor across cross‑functional teams. This role extends beyond execution, requiring a proactive leader who can independently review materials, interpret evolving FDA guidance, and pivot regulatory strategy to support business objectives while mitigating risk. Key Responsibilities Serve as a strategic regulatory partner to cross‑functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams Act as a trusted subject matter expert (SME) in FDA Advertising & Promotion regulations, providing high‑level guidance on complex regulatory scenarios Independently review and approve promotional and non‑promotional materials, ensuring compliance with applicable FDA regulations, guidance, and industry standards (e.g., OPDP requirements) Proactively interpret and apply FDA guidance, identifying risks and opportunities to inform sound regulatory strategy Demonstrate the ability to pivot regulatory strategy based on evolving FDA expectations, enforcement trends, and business needs Provide strategic input early in the development lifecycle, influencing messaging, claims, and communication strategy Partner with Legal and Medical Affairs to ensure balanced, compliant, and scientifically accurate communications Lead discussions on risk assessment and mitigation strategies, offering solutions‑oriented recommendations Support and, where needed, lead regulatory review committees (e.g., PRC/MLR), driving efficient and compliant review processes Stay current with regulatory trends, FDA warning letters, and industry best practices, proactively sharing insights with internal stakeholders Mentor junior team members and contribute to building organizational regulatory capability 7+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, with a strong emphasis on Advertising & Promotion Deep and demonstrated knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activities Proven ability to act as a strategic advisor and trusted partner to senior stakeholders Extensive experience collaborating with Medical Affairs, Legal, and Commercial teams Demonstrated ability to independently review promotional materials and make sound regulatory decisions Strong experience in interpreting and applying FDA guidance to real‑world scenarios, including the ability to adapt strategies accordingly Excellent communication, influence, and stakeholder management skills Strong critical thinking and problem‑solving abilities, with a proactive and solutions‑oriented mindset

We are seeking a highly strategic and experienced Senior Regulatory Consultant – Advertising & Promotion to serve as a trusted advisor across cross‑functional teams. This role extends beyond execution, requiring a proactive leader who can independently review materials, interpret evolving FDA guidance, and pivot regulatory strategy to support business objectives while mitigating risk. Key Responsibilities Serve as a strategic regulatory partner to cross‑functional stakeholders including Medical Affairs, Legal, Commercial, Marketing, and Clinical teams Act as a trusted subject matter expert (SME) in FDA Advertising & Promotion regulations, providing high‑level guidance on complex regulatory scenarios Independently review and approve promotional and non‑promotional materials, ensuring compliance with applicable FDA regulations, guidance, and industry standards (e.g., OPDP requirements) Proactively interpret and apply FDA guidance, identifying risks and opportunities to inform sound regulatory strategy Demonstrate the ability to pivot regulatory strategy based on evolving FDA expectations, enforcement trends, and business needs Provide strategic input early in the development lifecycle, influencing messaging, claims, and communication strategy Partner with Legal and Medical Affairs to ensure balanced, compliant, and scientifically accurate communications Lead discussions on risk assessment and mitigation strategies, offering solutions‑oriented recommendations Support and, where needed, lead regulatory review committees (e.g., PRC/MLR), driving efficient and compliant review processes Stay current with regulatory trends, FDA warning letters, and industry best practices, proactively sharing insights with internal stakeholders Mentor junior team members and contribute to building organizational regulatory capability 7+ years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry, with a strong emphasis on Advertising & Promotion Deep and demonstrated knowledge of FDA regulations, guidance documents, and enforcement trends related to promotional activities Proven ability to act as a strategic advisor and trusted partner to senior stakeholders Extensive experience collaborating with Medical Affairs, Legal, and Commercial teams Demonstrated ability to independently review promotional materials and make sound regulatory decisions Strong experience in interpreting and applying FDA guidance to real‑world scenarios, including the ability to adapt strategies accordingly Excellent communication, influence, and stakeholder management skills Strong critical thinking and problem‑solving abilities, with a proactive and solutions‑oriented mindset