Associate Director, Global Labeling Lead

BioNTech • Berkeley Heights, NJ

2d

About The Position

You will be a member of the Global Labeling, Global Regulatory Affairs team and will lead all Labeling activities required for the development and maintenance of the Company Core Data Sheet, US prescribing and patient information and EU CP prescribing and patient information for BioNTech commercial products. In your role, you will act globally and work cross-functionally.

Requirements

• Degree in pharmacy, chemistry, biology, biochemistry, medicine or equivalent
• 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
• Profound experience in leading the preparation and revision of product prescribing (and corresponding patient) information during registration and/or post-marketing, 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

Nice To Haves

• Advanced degree preferred, but not required

Responsibilities

• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level