Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 10671
About the role: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.
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
- 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
Your 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). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.
BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:
- 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
...and more! More details to be shared.
Apply now - We look forward to your application!Apply for our Cambridge, US; Gaithersburg, US; New Jersey, US location and simply send us your documents using our online form.
