Director Global Regulatory Affairs - CMC

Director Global Regulatory Affairs - CMC

Mainz, Germany;
London, United Kingdom;
Munich, Germany | full time | Job

You will lead all aspects of Regulatory Affairs CMC of Investigational Medicinal Products in clinical development. You will bring new medicinal products on the market. As you guide the products along this exciting path, you will establish new regulatory paths and define requirements for these next generation of therapeutics. In your role, you will act globally and work cross-functionally.

• 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 optimise harmonised 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 in support of our diverse employee base. 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. The final requirements for the individual use of our benefits are based on the company’s internal policies and applicable law.

Apply now by sending us your application documents including Curriculum Vitae, copy of , copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘Hire Right’. You will be informed accordingly by your BioNTech‑Recruiter.

We are looking forward receiving your application.

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