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Pharmaziepraktikant (m/w) Regulatory Affairs

Req #: 1800879
Location: Munich, BY DE
Job Category: Human Resources
Work Location: Joseph-Wild-Strasse 20 MÜNICH 81829
Organization: Celgene GmbH
Schedule: 40
Employee Status: Full time
Job Type: Fixed Term
Job Level:
Other Locations:Germany- Munich


Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Responsibilities include, but are not limited to:

Support of the Regulatory Affairs team in:

  • Marketing authorisation and variation procedures, especially regarding the product information (review of English drafts and German translations), implementation of product information changes locally (e.g. creation/change of print version of the SmPC, web-presentation), review of packaging components, maintenance of the “Rote / Gelbe Liste”
  • Clinical Trial Applications (CTAs): review of country specific CTAs/ amendments, translation of respective authority correspondence, translation/review of clinical trial labelling (English/German)
  • Organization of Regulatory meetings, e.g. scientific advice with German health authorities
  • Timelines of new products / new indications or other relevant regulatory information for cross-functional exchange, e.g. with Market Access

Skills/Knowledge Required:

  • Strong identification with the values of Celgene
  • Very good knowledge of German and good English language skills in writing and orally
  • Good understanding of pharmaceutical / medical terminology
  • Sound knowledge of Microsoft Office applications
  • Precise and reliable way of working with an "eye for detail"
  • Solution-oriented thinking and acting
  • Team player
  • Enthusiasm and quick perception

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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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