Associate Director, Global Labeling Lead

This is a fully remote position, open to applicants in New Jersey, +2 more states.

📋 Description

• Develop and implement the labeling strategy for the global life cycle management of medicinal products under BioNTech's purview for Primary Reference Labeling (including the Company Core Data Sheet [CCDS], US Prescribing Information [USPI], and EU CP Summary of Product Characteristics [SmPC]).

• This strategy includes managing local market label dependencies and differences among countries when there is a need to review the Primary Reference at the Labeling Team level.

• Construct and lead cross-functional Labeling Teams.

• Accountable for the timely preparation of updates to Primary Reference labeling following CCDS updates or as requested by relevant Health Authorities.

• Ensure prompt communication of updated CCDS content to local country offices for Marketing Authorizations (MAs) under BioNTech’s management.

• Oversee the development and maintenance of regulatory processes and systems for Global Labeling.

• Identify key Regulatory Labeling challenges and proactively implement solutions, including leading Labeling initiatives within Global Regulatory Affairs (GRA) or across BioNTech functions.

• Serve as the authorized delegate for the Head of Global Labeling as required.

⛳️ Requirements

• A degree in pharmacy, chemistry, biology, biochemistry, medicine, or a related field.

• An advanced degree is preferred but not mandatory.

• 9-16 years of professional experience in Regulatory Affairs globally, covering development, registration, and/or post-marketing for Biologics, Vaccines, and/or Small Molecules, with direct experience in the strategic development and management of Labeling content and interaction with Health Authorities.

• Extensive experience in preparing and revising product prescribing (and corresponding patient) information during registration and/or post-marketing, specifically for CCDSs, EU CP SmPCs, and USPIs.

• In-depth knowledge of EMA and FDA regulatory requirements for product prescribing and patient information.

• Capable of working independently on highly complex projects with minimal supervision.

• Exceptional verbal and written communication skills in English.

🏝️ Benefits

• Medical, Dental, and Vision Insurance.

• Life, AD&D, and Critical Illness Insurance.

• Pre-tax HSA & FSA, and DCRA Spending Accounts.

• 24/7 Employee Assistance & Concierge Program (EAP) available.

• 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.