Associate Director, Global Labeling Lead

BioNTech•Berkeley Heights, NJ

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