Associate Director* Regulatory Affairs CMC (SmMo and mAbs projects)
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.
Associate Director* Regulatory Affairs CMC (SmMo and mAbs projects)
Through your innovation, passion and unity with your colleagues you can become a pioneer in our Global Regulatory Affairs Team. In this position, you will lead all aspects of Global Regulatory Affairs CMC for Investigational Medicinal Products in a clinical program of the Protein-based & NCEs in order to bring new medicinal products on the market. As you guide the products along this exciting path, you will establish new regulatory routes and define requirements for these next generations of therapeutics. You will also get the opportunity to act globally and work cross-functionally.
Your main responsibilities are:
- Act as global regulatory affairs CMC lead for the assigned development and/or commercial products in alignment with the Global Regulatory Affairs CMC strategy
- Plan and prepare all CMC related aspects for the interactions with national authorities and supra-national agencies in the scope of products under development up to Marketing Authorisation and/or in the life cycle
- Execute the defined regulatory CMC dossier strategy incl. defined content for product under development and/or commercial; coordinate preparation, author (e.g. briefing books and CMC sections in the IB) and review the regulatory CMC submission packages incl. sources documents
- Apply harmonized regulatory CMC processes and systems as well as contribute to their adjustments and continuous optimization. Collaborate with internal and external stakeholder using regulatory CMC standards and processes
- Manage regulatory compliance activities (i.e. periodic regulatory reporting, review of technical documents, regulatory assessments on deviations, CAPAs & change controls) for the assigned product
- 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 projects
What you have to offer:
- Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
- At least 9 years professional experience in Global Regulatory Affairs CMC during clinical, registration and/or post-marketing for Biologics, Vaccines and 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:
- Flexible Working Time
- Mobile Office
- Work from EU Countries (up to 20 days per year)
- Company Pension Scheme
- Childcare
- Jobticket
- Company Bike
- Leave Account
- Fitness Courses
... and much more.
Have we kindled your pioneering spirit?
Then apply now for our location Mainz K1 and simply send us your application documents using our online form.
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 5879 (please indicate for inquiries)
We look forward to your application!
*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!
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