Senior Regulatory Advertising & Promotion Associate
durham, North Carolina | Jun 6
The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). Act as the regulatory subject matter expert providing review, guidance, strategic advice, and approval of advertising and promotional materials for all approved products and indications, including branded and disease education materials, with minimal direction from ad/promo leadership, while collaborating cross functionally to ensure timely, accurate reviews that meet business-critical timelines and regulatory requirements Apply extensive scientific and pharmaceutical expertise to serve as a key regulatory decision maker and advisor on the Promotional Review Board, independently evaluating, defending, and communicating regulatory comments and concerns with both the review board and commercial teams to ensure shared understanding and adherence to regulatory compliance expectations Support critical new product and new indication launches by providing scientific and regulatory expertise on proposed claims and promotional concepts, coordinating review activities for new promotional materials, and planning and scheduling OPDP submissions to meet essential launch timelines and organizational priorities Independently interpret and apply new or revised FDA regulations, guidances, and compliance considerations related to pharmaceutical advertising and promotion, ensuring promotional materials align with FDA and FTC requirements, assessing the evolving regulatory environment, and maintaining accountability for the regulatory integrity and compliance of all FDA-submitted promotional materials Exercise independent judgment to determine OPDP submission requirements and ensure accurate and timely submission of advertising and promotional materials to the Office of Prescription Drug Promotion using FDA Form 2253 through the Veeva system in compliance with FDA regulations Perform all other duties as assigned Minimum Requirements Associate degree in a relevant field, and 7+ years of experience in pharmaceutical/biotech, or Bachelor’s Degree in a relevant field, and 5+ years of experience in pharmaceutical/biotech, or Master’s Degree in a relevant field, and 3+ years of experience in pharmaceutical/biotech, or Doctor of Pharmacy (PharmD) in a relevant field, and 0+ years of experience in pharmaceutical/biotech Ability to provide regulatory knowledge, guidance, and risk assessments to cross-functional teams Demonstrated understanding of FDA’s submission requirements and drug/biologic/device development processes Good oral and written communication skills Detail-oriented, self-directed, and ability to handle multiple projects across all functional areas independently Proficiency with Microsoft Office platforms, including Word, Outlook and PowerPoint Preferred Qualifications 1+ years of experience in managing OPDP submissions 1+ years of experience in pharmaceutical advertising and promotion or related health/science field; experience with Veeva PromoMats preferred Regulatory Affairs Certifications (RAC)-RAPS Ability to drive accountability and responsibility that enables others to act with integrity Experience with Veeva PromoMats Technical knowledge in eCTD compliant submissions and experience with Veeva Vaults Experience working directly with OPDP Job Location This role is based in our Durham, NC office. At United Therapeutics, our mission and vision are one.
Full-Time