Regulatory Affairs Officer

About the role

We are looking for an experienced Regulatory Affairs Officer to lead and coordinate pharmaceutical regulatory activities in Switzerland. The role will focus on managing marketing authorisation submissions, maintaining existing authorisations and supporting export markets.

Key responsibilities

• Lead preparation and submission of marketing authorisation applications in Switzerland.
• Maintain existing authorisations, handling indication changes, technical modifications, commitments and renewals.
• Support applications, variations and renewals for export (MENA) markets in close collaboration with local teams.
• Develop regulatory strategies for CMC changes, product acquisitions and due‑diligence activities.
• Perform regulatory assessments and manage actions arising from change‑control requests.
• Monitor CH and EU pharmaceutical regulations and ensure ongoing compliance.
• Create and maintain internal SOPs, databases and IT tools to streamline regulatory processes.
• Collaborate with Medical Information, Pharmacovigilance and other departments to ensure regulatory compliance.
• Assist in the review and approval of promotional materials in Switzerland as required.

Required profile

• Master’s degree in pharmacy or a related life‑science discipline.
• At least 5 years of experience in EU or Swiss pharmaceutical regulatory affairs.
• Proven experience with CMC and product labeling.
• Hands‑on experience preparing and submitting eCTD dossiers.
• Fluent in English (written and spoken); French is a strong asset.

Required skills

• eCTD preparation and electronic submission.
• CMC management and regulatory strategy development.
• Regulatory submission preparation and maintenance.
• Pharmaceutical labeling expertise.