Associate Director, Global Labeling Lead

BioNTech; Greater London; On-site; GBP 107,000 - GBP 173,000; Full time

Job summary

A leading biotechnology company in Greater London seeks a Regulatory Affairs professional to lead Labeling activities for its products. The role involves defining and executing labeling strategies, building cross-functional teams, and ensuring compliance with regulatory requirements. Candidates should have 9-16 years of experience in Regulatory Affairs and a relevant degree. This position offers an opportunity to make a significant impact on global labeling while working in a collaborative environment focused on advancing innovative therapies.

Benefits

Medical, Dental and Vision Insurance

401(K) Plan with Company Match

Paid Time Off

Tuition Reimbursement & Student Loan Assistance

Qualifications

• 9-16 years of professional experience in Regulatory Affairs globally.
• Direct experience in Labeling content development.
• In-depth knowledge of EMA and FDA regulatory requirements.

Responsibilities

• Define and execute Labeling strategy for global life cycle management.
• Lead cross-functional Labeling Teams.
• Ensure timely preparation of Primary Reference labeling updates.

Skills

Regulatory Affairs knowledge

Labeling content development

Strong communication skills

Team leadership

Education

Degree in pharmacy, chemistry, biology or equivalent

Advanced degree preferred

Job description

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Cambridge, US; Gaithersburg, US; London, United Kingdom; New Jersey, US | full time | Job ID:10664

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 main responsibilities are:

• 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

What you have to offer:

• 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

What we offer:

At BioNTech, you will contribute to transforming the future of medicine while shaping a best‑in‑class Global Labeling function. You will work in an agile, science‑driven environment with:

• High strategic visibility in a global role at the interface of science, regulation and patient impact
• Close collaboration with senior leaders and cross‑functional experts across the organization
• The opportunity to build and refine global labeling standards, processes and systems in a rapidly evolving portfolio
• A culture that values ownership, innovation, integrity and continuous learning

If you are passionate about advancing innovative therapies to patients worldwide and want to shape global labeling at scale, we look forward to receiving your application.

Expected Pay Range: $146,300 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
• 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; London, United Kingdom; New Jersey, USlocation and simply send us your documents using our online form.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

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BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encouragecreativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!