Global Regulatory Affairs Manager - ATMP

Global Regulatory Affairs Manager - ATMP

Miltenyi Biotec

Bergisch Gladbach, Germany

Job Description

  • As Regulatory Affairs representative in a matrix organisation you will be responsible for managing investigational and approved advanced medicinal therapy products on a national or international basis (EU and other regions of the world);
  • This includes operational responsibility for one or more investigational and/or approved products as well as providing regional regulatory strategy and planning in line with the global regulatory strategy;
  • Working closely with health authorities to coordinate, communicate and manage all regulatory interactions is another essential part of this position;
  • You will also contribute relevant aspects of product safety and quality regarding pharmacovigilance and regulatory requirements;
  • Managing the development and maintenance of prescribing information and risk management plans completes the diverse range of responsibilities.


  • M.D., Ph.D., or other degree in pharmacy, biology, chemistry, or a related field. An advanced degree or certificate in regulatory science is preferred, but not required;
  • Several years of relevant experience in EU regulatory affairs, drug development and/or submission management with a focus on ATMPs and biologics;
  • Sound business judgment and collaborative skills, as well as proven ability to interact and influence at all levels of a dynamic organization;
  • Ability to build and maintain strong cross-functional relationships, to challenge traditional views while respecting best practices, and to present and argue cases in a professional and respectful manner;
  • You are a self-starter with excellent organizational and communication skills in English, basic skills in German are preferred, but not required. Willingness to travel internationally (10%).

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