Director Regulatory Affairs CMC
- Research, development, teaching
Become a member of the BioNTech Family!
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.
Associate* Director Regulatory Affairs CMC
Your main responsibilities are:
- Act as global regulatory CMC lead for assigned development programs/projects of a therapeutic and define and execute Regulatory CMC Strategy from pre-clinical stage up to (including) Marketing Authorization. Internal regulatory consultancy for different teams
- Identify critical Regulatory CMC development issues and proactively implement activities for their resolution. If appropriate: define and execute Regulatory CMC Strategy for commercial products in post-marketing phase incl. life-cycle management
- Plan, prepare and conduct all CMC related topics/aspects for interactions with national authorities and sovra-national agencies (e.g., MPA, PEI, EMA, FDA, as well as WHO when relevant) in the scope of product development incl. market authorization. If appropriate interaction supporting post-marketing phase of a commercial product
- Define for regulatory CMC content of regulatory application and dossiers for product development, marketing authorization and maintenance. Activities includes coordination of preparation, writing and reviewing of documents and dossiers (e.g. briefing book, IMPDs, INDs, MAA M3, variations, deficiency letters, PSFs, PSDs) Dossier compliance management
- Identify and support continuous optimization of regulatory CMC processes and interfaces (internal and external). Give regulatory consultancy to internal CMC groups.
- Regulatory Intelligence: Monitoring of changes and evolution in the regulatory CMC landscape for therapeutics; analyze the impact of drug changing regulations for the relevant platforms; collect, evaluate, and disseminate relevant regulatory updates on competitors´ developments
What you have to offer.
- Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
- At least 5 years professional experience in Global Regulatory Affairs CMC during clinical development and/or registration for Biologics, Vaccines and/or Small Molecules
- 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
- Good combination of strategic and operational skills; ability to make flexible, but thorough decisions in a highly dynamic environment
- Excellent communication skills in English and German
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
Have we kindled your pioneering spirit?
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).
Job-ID 6642 (please indicate for inquiries)
We look forward to your application!
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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