Senior Regulatory Affairs Manager (m/w/d)

Ort: Deutschland
Gehalt: a. A.
Spezialisierungen: Life Sciences
Vertragsart: Festanstellung
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Senior Regulatory Affairs Manager (m/w/d)

This position is to be filled full-time or parttime.

This tasks are awaiting you:

  • Planning and implementation of approval procedures in the EU (MRP, DCP, CP and purely national procedures) and in emerging markets as well as of lifecycle management procedures (e.g. variations, renewals, MAH transfer) worldwide
  • Strategic input and definition of regulatory strategies regarding definition of intelligent new marketing authorization application strategies, smart approaches such as worksharing procedures and various others
  • Contribution to and elaboration of current and/or upcoming regulatory topics of strategic impact within the EU and outside, preferably also creation of summaries or evaluations of current regulatory trends to share with our clients etc.
  • Communication and interaction within the project team, with customers, local partners and authorities in a regional and/or an international context
  • Planning, coordination and moderation of client project kick-off meetings as well as regular client project meetings
  • Coordination and support in preparation of proposals or contractual arrangements with our clients in accordance with the respective client needs and interests
  • Revision of approval documents and labeling management including tracking of updates and implementation

What you need to get started:

  • You have successfully completed a degree in pharmacy, medicine or other life sciences
  • You have at least 5 years of professional experience in marketing authorizations with a focus on the EU. Experience in regulatory applications and handling of non-EU marketing authorization procedures is highly advantageous
  • You have sound knowledge of current pharmaceutical and regulatory requirements (EU) and a good understanding of local requirements preferably in one ICH region
  • You have experience in project management, you are multi-tasking capable, enjoy liaising with different customers and approaching them and have an affinity for databases and project management software
  • You bring some experience and/or affinity in preparation of proposals or contractual arrangements with our clients
  • You speak fluent business English, preferably a second language with at last grade B2 completes your profile
  • You are a team player, communicative, conscientious, accurate and responsible
  • Flexible and willing to travel
  • Confident with MS Excel and MS Word

Your contact person for this position is Miss Franziska Mayr

You can reach her directly at:

T: +49 (0)89 5519 7774

M: f.mayr(at)progressive.de

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