Job description

We are looking for an experienced consultant in regulatory affairs with expertise in the Swiss regulatory affairs environment & navigating Swissmedic processes.

As a consultant you will provide strategic and operational regulatory support within drug development at a national level. Your responsibilities will include managing and participating in complex and challenging projects from international and local companies across various therapeutic areas.

    Regulatory Strategy with Swissmedic focus:

  • Provide regulatory support to clients, propose registration strategies for new product developments, line extensions, and product maintenance plans.
  • Advise on the content and timing of submissions particularly for Swissmedic submissions
  • Provide regulatory advice on drug development strategies from early stage to marketing authorisation applications, variations, and renewals
  • Support clients in organising and conducting scientific advice procedures and other meetings with Swissmedic. Including preparing briefing documents, managing relevant contacts and meetings
  • Marketing authorisation applications & license maintenance
  • Manage marketing authorization applications for Swissmedic, overseeing coordination and responses to authority questions, along with post-marketing commitments
  • Co-ordinate and support preparation of regulatory documents (e.g., Swiss Module 1, including product information and mock-ups,)
  • Manage license maintenance applications, including variations, line extensions, renewals, and PSUR submissions, under the respective scheme
  • Ensure content and format of CTD documentation comply with current requirements and guidelines
  • Act as a Swissmedic specialist for international collaboration projects such as Project Orbis and Access Consortium
  • Advise and support clients with Swiss MAA and MAH requirements

    Qualifications / Experience
  • A university degree in a scientific discipline
  • Experience in the Swiss regulatory affairs environment
  • Experience in regulatory writing (e.g., Scientific Advice Briefing Book, CTD Modules, ODD applications)
  • Proficient in German and English; additional proficiency in French and/or Italian is advantageous
  • Demonstrate excellent communication skills and a high level of intercultural awareness

    Application & Contact

Send your application (CV and letter) to with the subject line: Consultant, Switzerland

Contact information