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Regulatory Affairs Consultant - Switzerland & Germany

Regulatory Affairs Consultant - Switzerland & Germany

PharmiwebLugano, CH
Vor 21 Tagen
Stellenbeschreibung

Are you a fluent German speaker with expertise in regulatory affairs? Do you have a passion for navigating the complex world of pharmaceutical regulations in Germany, Switzerland, and the EU? We are seeking a talented and experienced Regulatory Affairs Consultant to join our dynamic team!

The role can be home or office based in various European locations.

Key Responsibilities :

  • Provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland
  • Support national dossier filings and contribute to centralized dossier preparation
  • Offer expert advice on new product applications and lifecycle maintenance
  • Lead small-scale projects or work streams, ensuring client satisfaction and project success
  • Collaborate with cross-functional teams to deliver high-quality regulatory solutions

Ideal Candidate Profile :

  • University degree in a scientific area
  • Several years of experience in regulatory affairs, specifically in German and Swiss markets
  • Experience working with Swissmedic and BfArM
  • In-depth knowledge of international regulatory requirements
  • Strong understanding of EU regulatory landscape
  • Excellent project management and client communication skills
  • Ability to work independently and as part of a team
  • Proactive problem-solver with keen attention to detail
  • Fluent English and German speaker (required)
  • LI-REMOTE