Senior Director Global Regulatory Affairs CMC

Mainz, Germany; Cambridge, US; London, United Kingdom | full time | Job ID: 7050

In this position, you will lead all aspects of Global Regulatory Affairs CMC for the mRNA-based individualized neoantigen-specific immunotherapy (“iNeST”) on the way through clinical development to the market. The iNeST immunotherapies are individualized cancer therapies tailored to a specific patient’s tumor and is being jointly developed by BioNTech and Genentech. Furthermore, you will lead the Global Regulatory Affairs CMC team of the iNeST / IVAC platform and support Regulatory CMC activities for all platform products. As you contribute essentially to the development of the products and their manufacturing process including the target mutation discovery and selection processes with bioinformatic tools. 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:

• Lead and develop the IVAC GRA CMC team as acting as functional and line manager. Ensure education and training of the team members to guarantee that experiences and know-how is available to meet requirements from the projects and development stages.
• Define and execute the Global Regulatory CMC strategies for the respective products and medical devices in i) development towards global Marketing Authorisation, and ii) post-marketing phase. Act as global regulatory affairs CMC lead for assigned late stage or complex development and/or commercial products and/or projects.
• Define the strategy and lead the interactions with national authorities and sovra-national regulatory agencies in the scope of CMC aspects including the design of highly personalized products with bioinformatic tools. Further, oversee interaction strategies for all products of the IVAC platform and ensure alignment within the product group.
• Define and lead the regulatory CMC dossiers strategy, content and appropriateness for the respective development and commercial products (lifecycle maintenance); coordinate the preparation and review the regulatory CMC submission packages incl. sources documents.
• Collaborate with internal and external stakeholders involved in the development of IVAC products and companion diagnostics.
• Regulatory Intelligence: Monitor changes and evolution as well as contribute to forming the regulatory CMC landscape in particular for individualized mRNA-based immunotherapies and medical devices.

What you have to offer:

• Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
• At least 15 years professional experience in Global Regulatory Affairs CMC during clinical development and/or registration for Biologics. Further experiences in development of medical devices for 2 years are beneficial.
• 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

Inspired? Join our team of pioneers and bright, open minds. From our founders to our

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Together, we usher in a new era of immunotherapies and work on realizing our vision.

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At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to

revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide,

especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop

business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and

become part of a mission that has the potential to change lives around the world.

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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!