Project Manager Regulatory Affairs

Project Manager Regulatory Affairs

Sanofi

Vienna, Austria

Job Purpose:

The Regulatory Affairs Project Manager essentially supports the Austrian Regulatory Team in the daily business operations. She or he is also responsible for her/his own projects and coordinates all communication related to a project, both within the Regulatory Department - as well as with other cross-functional teams at the Multi-Country Organization level (Austria-Germany-Switzerland).

Main responsibilities:

  • Work closely with all members of the team in managing general regulatory projects;
  • Manage day-to-day operational aspects of a project and scope;
  • Ensure project documents are complete, current, and stored appropriately;
  • Minimize exposure and risk on regulatory projects;
  • Support life-cycle management prescription and non prescription medicines, medical devices and cosmetics;
  • Submissions of variations/archiving;
  • Database management;
  • Text translations/updates;
  • Artwork management.

Profile:

  • Master Degree in Life Sciences, preferably Pharmacy;
  • Working experience in pharmaceutical industry preferred;
  • MS Office; databases, eCTD (Electronic Common Technical Document) experience preferred;
  • Accurate and precise working attitude;
  • Reliable and pro-active;
  • Organizational skills;
  • Fluent level of English;
  • At least working knowledge of German.

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Sanofi     Austria     Clinical Research     Regulatory Affairs     3 - 4 Years Experience     5 Years+ Experience    

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