Associate Director, Global Labeling Lead (remote)
Your contribution:
Define and execute Labeling strategy for global life cycle management of medicinal products in BioNTech's responsibility for Primary Reference Labeling (i.e., the Company Core Data Sheet (CCDS), US Prescribing Information (USPI) and EU CP Summary of Product Characteristics [SmPC]). The strategy comprises management of local market label dependencies and country label differences when the local markets identify a need to review Primary Reference at the Labeling Team level
Build and lead cross-functional Labeling Teams
Responsible for timely preparation of Primary Reference labeling updates following update of the CCDS or on request of competent Health Authorities
Ensuring timely communication of updated CCDS content 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 implement activities for their resolution including leading initiatives for Labeling within GRA or across functions at BioNTech
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, but not required
- 9-16 years of professional working experience in Regulatory Affairs globally during development, registration and/or post-marketing for Biologics, Vaccines and/or Small Molecules, including direct experience in strategic Labeling content development and management and interacting with Health Authorities
- 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 and remuneration:
Expected Pay Range: $146,300/year to 234,100/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance).
BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce.
- 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