(Senior) Manager Drug Regulatory Affairs (m/f/d)

Fresenius Kabi AG

Jobbeschreibung

We have a clear commitment: putting best-possible solutions in the hands of medical professionals, enabling them to find the right answer to the challenge they face. Fresenius Kabi is a driver of healthcare for the coming decade. We truly live diversity and value different backgrounds and motivations....+ ←


  • Regulatory support of international pharmaceutical marketing authorisations
  • Planning, implementation and coordination of European procedures (MRP/DCP)
  • Strategic planning and implementation of variations in and outside Europe
  • Establishing and maintaining relationships with regulatory authorities and relevant third parties
  • Supporting the local market units in terms of regulatory tasks
  • Participating in projects by contributing regulatory expertise
  • Monitoring the regulatory environment and assessing its relevance for the product portfolio

  • You have a completed University degree in sciences
  • You bring at least 3 years of work experience in European and international drug regulatory affairs
  • You have a structured working style, you are detail-oriented, a team player and a problem solver
  • You are known for your high level of precision and strategic thinking
  • You have very good communication skills
  • You have very good English language skills (written & spoken)
  • You have good IT skills and an interest in regulatory IT topics
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