Manager* Regulatory Affairs CMC
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.
Manager* Regulatory Affairs CMC
Your main responsibilities are:
- Responsible for regulatory CMC content of regulatory application and dossiers for product development, marketing authorisation and maintenance. Activities include coordination of preparation, writing and reviewing of documents and dossiers (e.g. briefing book, IMPDs, INDs, MAA M3, deficiency letters)
- Act as global regulatory CMC lead for assigned development programs of a therapeutic and execute Regulatory CMC Strategy from pre-clinical stage throughout development to (supporting) Marketing Authorisation. Internal regulatory consultancy for different stakeholders. Identify critical Regulatory CMC development issues and support their resolution.
- 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 authorisation. If appropriate interaction supporting post-marketing phase of a commercial product.
- Regulatory Intelligence: Monitoring of changes and evolution in the regulatory CMC landscape for therapeutics; analyse the impact of drug changing regulations for relevant plattforms
What you have to offer.
- Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
- At least three years of professional experience in regulatory affairs CMC and/or MDRA
- Solid experience in preparation, revision and maintenance of regulatory CMC documents for clinical trial approvals (IMPD, IND) and marketing authorisations (BLA, MAA)
- Extensive knowledge in CMC drug development and relevant functions, preferred biologics (antibodies)
- Very good knowledge of the relevant laws and guidelines as well as experience in the implementation and optimisation of processes and data management systems
- Organisational talent, analytical and conceptual skills as well as excellent communication skills in English (written and spoken)
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 6831 (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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