Associate Director, Global Regulatory Affairs - Ad / Promo

About the Position

Associate Director, Global Regulatory Affairs - Ad / Promo

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

We are looking for an Associate Director in Regulatory Affairs, Advertising and Promotion to join our team at BioNTech. In this role, you will ensure our promotional materials and medical communications comply with FDA regulations, contributing to our mission of developing innovative therapies that improve global health.

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.

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.
• Experience in oncology is a plus.

We Offer

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.

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Benefits include but are not limited to:

• 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

…and more! More details to be shared.

About the Company

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

BioNTech - As unique as you

BioNTech

Apply now - We look forward to your application!

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.

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