Associate Director, Global Regulatory Affairs - Ad / Promo
About The Position
As an Associate Director in Regulatory Affairs, Advertising and Promotion at BioNTech, you will play a pivotal role in ensuring our promotional materials and medical communications comply with FDA regulations. Your expertise will directly contribute to advancing our mission of developing innovative therapies that improve global health. You’ll lead interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB), ensuring alignment with regulatory requirements while supporting our commercial success. Collaborating closely with cross-functional teams, you’ll help shape advertising strategies that uphold BioNTech’s commitment to integrity and excellence.
Requirements
- A Bachelor’s degree in a scientific discipline (minimum requirement) with significant experience in the pharmaceutical industry, including 5+ years in regulatory affairs.
- Deep knowledge of advertising promotion regulations and FDA guidance documents.
- Proven expertise in managing OPDP submissions and interactions with FDA regarding advertising materials.
- Strong collaborative skills to work effectively with Commercial, Medical Affairs, Legal, and other internal stakeholders.
Nice To Haves
- Experience in oncology is a plus.
Responsibilities
- Act as the internal subject matter expert on FDA Advertising & Promotion matters, providing regulatory advice for assigned products.
- Review and approve promotional materials using BioNTech’s content management systems to ensure compliance with FDA regulations.
- Oversee timely and accurate FDA 2253 submissions for U.S. promotional materials.
- Serve as the primary liaison with OPDP/APLB, managing high-quality submissions and responses to regulatory inquiries.
- Develop streamlined processes for promotional material reviews while maintaining adherence to policy standards.
- Provide training on FDA requirements, PhRMA DTC Guidelines, and company policies to enhance compliance across teams.
Benefits
- Medical, Dental and Vision Insurance
- Life, AD&D, Critical Illness Insurance
- Pre-tax HSA & FSA, DCRA Spending Accounts
- Employee Assistance & Concierge Program (EAP) available 24/7
- Parental and Childbirth Leave & Family Planning Assistance
- Sitterstream: Virtual Tutoring & Childcare Membership
- Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
- 401(K) Plan with Company Match
- Tuition Reimbursement & Student Loan Assistance Programs
- Wellbeing Incentive Platforms & Incentives
- Professional Development Programs
- Commuting Allowance and subsidized parking
- Discounted Home, Auto & Pet Insurance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
