Associate Director, Global Regulatory Affairs - Ad / Promo

Cambridge, US; New Jersey, US | full time | Job ID: 9842

About the role:

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.

Your contribution:

• 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.

A good match:

• 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.
• Experience in oncology is a plus.

Your benefits and remuneration:

Expected Pay Range: $168,100 to $268,700/year+ benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

• 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
• ... more! More details to be shared.

Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge’s thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.