Senior Associate / Associate Manager, Regulatory Affairs für swisslinx in Basel - myjob.ch
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      12.10.2025

      Senior Associate / Associate Manager, Regulatory Affairs

      • Basel
      • Festanstellung 100%

      • Merken
      • drucken
       

      swisslinx

      swisslinx

      Senior Associate / Associate Manager, Regulatory Affairs

      Job description:

      • Coordinate CTAs, amendments, orphan drug applications, paediatric plans, and annual reports.
      • Maintain product information and assess promotional materials.
      • Collaborate with internal stakeholders to implement regulatory strategy.
      • Assist in agency meeting preparation and briefing documents.
      • Track queries and commitments with regulatory agencies, ensuring timely responses.
      • Manage regulatory documents in internal systems, including submission tracking and archiving.

      Requirements:

      • 3-5 years of experience in a Regulatory Affairs capacity within the pharmaceutical industry.
      • Demonstrated interaction with SwissMedic and solid understanding of Swiss regulatory requirements.
      • Hands-on experience with CTAs and MAAs in Switzerland.
      • Strong understanding of the drug development process.
      • Excellent communication and planning skills, with a detail-oriented and proactive approach.

      Arbeitsort: Basel