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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.
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
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.
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.
Inspired? Become part of #TeamBioNTech.
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!
#J-18808-Ljbffr
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.
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
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.
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.
Inspired? Become part of #TeamBioNTech.
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!
#J-18808-Ljbffr