Director of Regulatory Affairs – Switzerland

About the role

Revolution Medicines is seeking a highly motivated Director of Regulatory Affairs for Switzerland to lead strategic regulatory activities for both early‑stage and marketed oncology products. The role sits on the local Management Team and collaborates closely with the European Regional Regulatory Team.

Key responsibilities

• Lead and provide strategic input on all Swiss regulatory activities, ensuring compliance with Swiss legislation, Swissmedic, ICH and company policies.
• Prepare and follow‑up national scientific consultations and pre‑submission meetings in collaboration with global regulatory teams.
• Coordinate risk‑mitigation materials, product packaging updates, and review of promotional content.
• Monitor national regulatory guidelines, communicate changes to regional and global teams, and contribute to new guideline development.
• Manage Swissmedic inspections, audits, quality defects, counterfeit issues, batch recalls and serve as the information officer.
• Develop and maintain regulatory procedures, SOPs, manuals and ensure appropriate staffing and training.

Required profile

• Master’s or PhD in a scientific or medical discipline.
• 10+ years of regulatory leadership experience in pharma/biotech, with a proven record of successful product launches.
• Strong knowledge of Swiss and EU regulatory frameworks and oncology therapeutic area.
• Excellent written and verbal communication, presentation, and networking skills.
• Ability to work independently in a fast‑paced environment and willingness to travel up to 20%.

Required skills

• Regulatory strategy and compliance for Swiss market.
• Swissmedic and ICH guideline expertise.
• Oncology product knowledge.
• Preparation of regulatory submissions and scientific consultations.