Act as global regulatory affairs CMC lead for the assigned development and/or commercial products and/or projects and define and execute the Global Regulatory CMC strategy from pre-clinical stage up to Marketing Authorisation and/or life cycle maintenance
Define the strategy of the interactions with national authorities and sovra-national regulatory agencies in the scope of CMC aspects for the assigned products
Plan, prepare and conduct all CMC related topics/aspects for the interactions in the scope of products under development up to Marketing Authorisation and/or in the life cycle
Define the regulatory CMC dossiers strategy, content and appropriateness for the respective development and commercial products (lifecycle maintenance); coordinate the preparation, author (e.g. briefing books and CMC sections in the IB) and review the regulatory CMC submission packages incl. sources documents
Implement and apply as well as adjust and continuously optimize harmonized regulatory CMC processes and systems
Collaborate with internal and external stakeholders using regulatory CMC standards and processes
Monitor changes and evolution in the regulatory CMC landscape for medicinal products and analyse the impact of changing regulations on BioNTech’s products and/or assigned project

Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
More than 9 years professional working experience in Regulatory Affairs CMC globally during clinical, registration and/or post-marketing for Biologics and/or Vaccines
Extensive experience in preparation and revision of regulatory CMC documents
Knowledge of CMC drug development (Drug Substance and Drug Product) and knowledge of multidisciplinary functions involved in drug development and manufacturing
Result-and goal-oriented
Excellent communication skills in English

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits
We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience
Note: The availability, eligibility and design of the listed benefits may vary depending on the location

Director, Global Regulatory Affairs – CMC

Key skills