Director Global Regulatory Affairs - CMC
BioNTech SEMainz, Rhineland-Palatinate, Germany • London, England, United Kingdom
Posted November 26, 2025
Full Time
About the Company
BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival.
Job Description
Lead all aspects of Regulatory Affairs CMC of Investigational Medicinal Products in clinical development, bringing new medicinal products on the market and establishing new regulatory paths.
Requirements
- Act as global regulatory affairs CMC lead for assigned development and/or commercial products and/or projects
- Define and execute the Global Regulatory CMC strategy from pre-clinical stage up to Marketing Authorisation and/or life cycle maintenance
- Plan, prepare and conduct all CMC related topics/aspects for interactions with national authorities and sovra-national regulatory agencies
- Implement and apply harmonized regulatory CMC processes and systems
- Monitor changes and evolution in the regulatory CMC landscape for medicinal products
Benefits
- Competitive remuneration packages
- Various benefits in support of diverse employee base