Associate Director, Global Labeling Lead
BioNTech SE
2 months ago
Remote friendly (Berkeley Heights, NJ)
United States
$146,300 - $234,100 USD yearly
Corporate Functions
Responsibilities:
- Define and execute Labeling strategy for global life cycle management of medicinal products for Primary Reference Labeling (Company Core Data Sheet/CCDS, US Prescribing Information/USPI, EU CP Summary of Product Characteristics/SmPC), including managing local label dependencies and country differences.
- Build and lead cross-functional Labeling Teams.
- Ensure timely preparation of Primary Reference labeling updates following CCDS updates or on request of competent Health Authorities.
- Communicate updated CCDS content to local country offices for Marketing Authorizations (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 Labeling initiatives within GRA or across functions.
- Act as empowered delegate for the Head of Global Labeling as necessary.
Qualifications / Required:
- Degree in pharmacy, chemistry, biology, biochemistry, medicine or equivalent.
- 9–16 years of professional experience in Regulatory Affairs globally during development, registration and/or post-marketing for Biologics, Vaccines and/or Small Molecules, including strategic Labeling content development/management and interaction with Health Authorities.
- Profound 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 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.
Preferred:
- Advanced degree.
Benefits:
- Medical, Dental and Vision Insurance; Life, AD&D, Critical Illness Insurance; Pre-tax HSA/FSA and DCRA Spending Accounts; 24/7 EAP.
- Parental and Childbirth Leave & Family Planning Assistance; Sitterstream virtual tutoring/childcare; Paid Time Off and holidays.
- 401(K) plan with company match; Tuition reimbursement & student loan assistance; Professional development; Commuting allowance/subsidized parking; discounted home/auto/pet insurance.
Application instructions:
- Apply online for Cambridge (US), Gaithersburg (US), London (UK) or New Jersey (US) by submitting documents via the online form.
- Background check may be conducted (HireRight).
- Define and execute Labeling strategy for global life cycle management of medicinal products for Primary Reference Labeling (Company Core Data Sheet/CCDS, US Prescribing Information/USPI, EU CP Summary of Product Characteristics/SmPC), including managing local label dependencies and country differences.
- Build and lead cross-functional Labeling Teams.
- Ensure timely preparation of Primary Reference labeling updates following CCDS updates or on request of competent Health Authorities.
- Communicate updated CCDS content to local country offices for Marketing Authorizations (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 Labeling initiatives within GRA or across functions.
- Act as empowered delegate for the Head of Global Labeling as necessary.
Qualifications / Required:
- Degree in pharmacy, chemistry, biology, biochemistry, medicine or equivalent.
- 9–16 years of professional experience in Regulatory Affairs globally during development, registration and/or post-marketing for Biologics, Vaccines and/or Small Molecules, including strategic Labeling content development/management and interaction with Health Authorities.
- Profound 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 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.
Preferred:
- Advanced degree.
Benefits:
- Medical, Dental and Vision Insurance; Life, AD&D, Critical Illness Insurance; Pre-tax HSA/FSA and DCRA Spending Accounts; 24/7 EAP.
- Parental and Childbirth Leave & Family Planning Assistance; Sitterstream virtual tutoring/childcare; Paid Time Off and holidays.
- 401(K) plan with company match; Tuition reimbursement & student loan assistance; Professional development; Commuting allowance/subsidized parking; discounted home/auto/pet insurance.
Application instructions:
- Apply online for Cambridge (US), Gaithersburg (US), London (UK) or New Jersey (US) by submitting documents via the online form.
- Background check may be conducted (HireRight).