Associate Director, Global Labeling Lead (remote)
BioNTech SE
June 24, 2026
Remote friendly (Berkeley Heights, NJ)
United States
Corporate Functions
Your contribution:
- Define and execute Labeling strategy for global life cycle management of medicinal products (Primary Reference: CCDS, USPI, EU CP SmPC), including management of local market label dependencies and country label differences.
- Build and lead cross-functional Labeling Teams.
- Prepare Primary Reference labeling updates timely after CCDS updates or upon request of competent Health Authorities.
- Communicate updated CCDS content timely to local country offices for MAs in BioNTech’s responsibility.
- Lead development and maintenance of regulatory processes and systems for Global Labeling.
- Identify critical Regulatory Labeling issues and proactively resolve them, including leading initiatives within GRA or across functions.
- Act as the empowered delegate for the Head of Global Labeling as necessary.
A good match:
- Degree in pharmacy, chemistry, biology, biochemistry, medicine, or equivalent.
- Advanced degree preferred.
- 9–16 years’ Regulatory Affairs experience globally for biologics, vaccines and/or small molecules (development/registration and/or post-marketing), including strategic Labeling content development/management and interaction with Health Authorities.
- In-depth experience leading preparation/revision of product prescribing (and corresponding patient) information for CCDSs, EU CP SmPCs and USPIs.
- In-depth knowledge of EMA and FDA regulatory requirements for product prescribing and patient information.
- Ability to work independently on very complex projects with minimal oversight.
- Excellent verbal and written communication skills in English.
Benefits:
- Expected pay range: $146,300–$234,100/year + benefits, annual bonus & equity.
- Medical, dental and vision; life/AD&D/critical illness; HSA/FSA/DCRA; EAP; parental/childbirth leave; paid time off; 401(k) match; tuition reimbursement/student loan assistance; professional development; commuting allowance/subsidized parking; discounted insurance.
Apply now:
- Submit documents via the online form for Cambridge, US; Gaithersburg, US; New Jersey, US.
- Define and execute Labeling strategy for global life cycle management of medicinal products (Primary Reference: CCDS, USPI, EU CP SmPC), including management of local market label dependencies and country label differences.
- Build and lead cross-functional Labeling Teams.
- Prepare Primary Reference labeling updates timely after CCDS updates or upon request of competent Health Authorities.
- Communicate updated CCDS content timely to local country offices for MAs in BioNTech’s responsibility.
- Lead development and maintenance of regulatory processes and systems for Global Labeling.
- Identify critical Regulatory Labeling issues and proactively resolve them, including leading initiatives within GRA or across functions.
- Act as the empowered delegate for the Head of Global Labeling as necessary.
A good match:
- Degree in pharmacy, chemistry, biology, biochemistry, medicine, or equivalent.
- Advanced degree preferred.
- 9–16 years’ Regulatory Affairs experience globally for biologics, vaccines and/or small molecules (development/registration and/or post-marketing), including strategic Labeling content development/management and interaction with Health Authorities.
- In-depth experience leading preparation/revision of product prescribing (and corresponding patient) information for CCDSs, EU CP SmPCs and USPIs.
- In-depth knowledge of EMA and FDA regulatory requirements for product prescribing and patient information.
- Ability to work independently on very complex projects with minimal oversight.
- Excellent verbal and written communication skills in English.
Benefits:
- Expected pay range: $146,300–$234,100/year + benefits, annual bonus & equity.
- Medical, dental and vision; life/AD&D/critical illness; HSA/FSA/DCRA; EAP; parental/childbirth leave; paid time off; 401(k) match; tuition reimbursement/student loan assistance; professional development; commuting allowance/subsidized parking; discounted insurance.
Apply now:
- Submit documents via the online form for Cambridge, US; Gaithersburg, US; New Jersey, US.