Director Global Regulatory Affairs Global Labeling Lead

Open for hire at one of the following locations –  Mainz K1, Cambridge Erie Street, London. - Job ID: 6310 

 

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.


 

Director Global Regulatory Affairs Global Labeling Lead 

 

Your main responsibilities are:
 

  • Define and execute labeling strategy for global life cycle management of product authorised medicinal products in BioNTech's responsibility for above-country Labeling (i.e., the CCDS, USPI and EU SmPC). The strategy comprises management of local markets label dependencies and country label differences when the local markets identify a request to review above-country.
  • Build and lead a global labeling team with some oversight from senior members in labeling
  • Responsible for timely submission of label updates following update of the company’s Core Data Sheet (CCDS) or on request of competent Health Authorities
  • Ensuring timely implementation of updated CCDS content into the local labels of MAs in BioNTech’s responsibility
  • Responsible for regulatory processes and systems applied for global label updates
  • Identify critical Regulatory issues and proactively implement activities for their resolution

 
What you have to offer:
 

  • Degree in pharmacy, chemistry, biology, biochemistry, medicine or equivalent
  • >6 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 labeling management 
  • Experience in leading the preparation and revision of product informative texts during registration and/or post-marketing, at least for EU/EEA and US
  • In depth knowledge of EMA and FDA regulatory requirements for product informative texts
  • Knowledge of multidisciplinary functions involved in global label update processes
  • Result-and goal-oriented
  • Excellent communication skills in English
     


 

Benefits for you

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Click here to find out more about what we do, the careers we offer and also the benefits we provide.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

 

Have we kindled your pioneering spirit? 

This vacancy is to be hired at one of the following locations – Mainz K1, Cambridge Erie Street, LondonApply now for your preferred job and location through our careers site.


*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!