Manager Regulatory Affairs 100% (f/m/d)

Bachem

📍 Bubendorf, Basel-Landschaft, Switzerland

Full-time Management & Operations

Job Description

To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our Regulatory Affairs (RA) team, we are looking for a (Senior) Regulatory Affairs Manager (permanent position, 100%, f/m/d).

You will take full responsibility for your assigned projects/tasks while benefiting from working within a highly motivated and innovative team.

Your tasks

  • Representation of RA in projects, including discussions and negotiations with the customers during the whole product lifecycle, i.e, from pre-clinical to marketed.
  • Close cross‑functional collaboration with a high diversity of internal stakeholders.
  • Development and tailoring of convincing regulatory strategies.
  • Delivery of regulatory advice to internal and external stakeholders.
  • Hands‑on writing and review of regulatory documents and dossiers in accordance with customer requirements and applicable regulatory rules and guidelines...
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