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Natural Scientist, Physician as Regulatory Affairs Manager CMC (f/m)

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CureVac is a biopharmaceutical company with a total of approximately 230 employees, with locations based in Tübingen and Frankfurt-on-Main. We are pioneers in the research and development of novel drugs based on the messenger RNA molecule. Our focus is on cancer immunotherapies and prophylactic vaccines, as well as on molecular therapies. In addition to SAP founder Dietmar Hopp, Microsoft founder Bill Gates is also among the investors and co-owners of CureVac.

To boost our team in Tübingen, we are looking to recruit a

Regulatory Affairs Manager CMC (f/m)

Job ID 4301-1503

Your Responsibilities:

  • Drawing up and coordinating high-quality regulatory documents in collaboration with the individual functions
  • Monitoring compliance with regulatory requirements and schedules
  • Incorporating regulatory requirements in CMC development
  • Responding to deficiency letters from authorities
  • Preparing regulatory documents for CTAs (Phase I, II, and III)
  • Identifying new regulatory requirements through ongoing further training
  • Incorporating new regulatory developments in the development strategy and internal work processes, including drawing up and revising work instructions in collaboration with the relevant functions

Your Qualification:

  • Degree from a college or university and, preferably, a doctorate in the field of natural sciences, biotechnology, pharmacy, veterinary medicine, or human medicine
  • Professional experience in regulatory affairs at national and international level with the authorities or in the pharmaceutical industry, including knowledge of licensing requirements and legislation
  • Experience with Biologicals Quality Module 3 Documentation
  • Business-fluent English and German, both written and spoken
  • Ability to work independently in a structured way and excellent communication skills
  • Regulatory and/or scientific/clinical experience in the area of biologics is an advantage

The vision of having a positive impact on people's lives and well-being drives us. Our highly motivated employees, and their quest for excellence, are integral to achieving that goal.

If you are a team player with an independent mind, drive, and focus, who wants to push the boundaries of an exciting new field of pharmaceutical development, please submit your application via our CareerPortal.

Regulatory-Affairs-Manager Regulatory-Affairs-Managerin Regulatory-Affairs-Management Naturwissenschaftler Naturwissenschaftlerin Naturwissenschaften Chemiker Chemikerin Chemie Biologe Biologie Biologie Biotechnologe Biotechnologin Biotechnologie Pharmazeut Pharmazeutin Pharmazie Mediziner Medizinerin Medizin Humanmedizin Veterinär Veterinärin Veterinärmedizin Drug-Regulatory-Affairs Arzneimittelprüfung Arzneimittelzulassung Arzneimittelerprobung Produktdokumentation Klinische Forschung Pharmaindustrie Pharmabranche Arzneimittelbranche Arzneimittelindustrie CureVac GmbH Tübingen 72076 ax50320by
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