Responsable affaires réglementaires

Job Title: Regulatory Affairs Manager

Location: Neuchâtel, Switzerland (On-site)

Employment Type: Full-time

Commencement: October 2026 or at a mutually agreed date

Languages

Required:

English (C1) and French or German (C1)

We are seeking an experienced Regulatory Affairs Manager with strong expertise in Swiss pharmaceutical regulations to manage regulatory submissions, marketing authorisation activities and lifecycle management for medicinal products in Switzerland.

The role requires a highly autonomous, pragmatic and solution-oriented professional with extensive hands‑on experience in Swiss Regulatory Affairs, capable of managing regulatory activities from strategy through submission and interacting directly with Swiss medic.

• Prepare, compile, submit and manage marketing authorisation applications for human medicinal products in Switzerland.
• Manage the lifecycle of existing marketing authorisations, including variations, renewals, notifications and other post‑approval regulatory activities.
• Develop and implement regulatory strategies for new and existing medicinal products and determine the appropriate Swiss regulatory pathways.
• Prepare, review and maintain Swiss eCTD dossiers, including clinical and non‑clinical modules and other regulatory documentation.
• Manage direct interactions with Swiss medic, including regulatory correspondence, requests for information, deficiency letters and responses to authority questions.
• Prepare, review and maintain Swiss product information, patient information, labelling, packaging texts and related regulatory documentation.
• Ensure regulatory activities comply with applicable Swiss laws, regulations and regulatory requirements governing medicinal products.
• Apply current Swiss medic guidance documents and relevant ICH guidelines to regulatory submissions and lifecycle activities.
• Monitor changes in Swiss pharmaceutical legislation and assess their impact on existing and planned medicinal products.
• Review medicinal product advertising and promotional materials for compliance with applicable Swiss laws, regulations and regulatory requirements.
• Provide regulatory guidance to Commercial, Marketing and Medical teams regarding promotional activities, HCP communications, digital content and other external communications relating to medicinal products.
• Support regulatory preparation for product launches and commercialisation in Switzerland.
• Coordinate regulatory activities with internal and external stakeholders, including Medical, Quality, Pharmacovigilance, Commercial, suppliers, manufacturers and strategic partners.
• Manage regulatory information systems, Ref Data, and maintain appropriate regulatory tracking and documentation.

• Master’s degree in Life Sciences, Pharmacy or another relevant scientific discipline.
• Minimum of 8 years of experience in pharmaceutical Regulatory Affairs.
• Extensive hands‑on experience with Swiss marketing authorisation procedures and lifecycle management for human medicinal products.
• Demonstrated ability to efficiently prepare, manage and submit marketing authorisation applications and lifecycle submissions from regulatory strategy through approval.
• Experience interacting directly with Swiss medic and managing regulatory authority questions through to resolution.
• In‑depth knowledge of the regulatory framework governing medicinal product authorisation in Switzerland and applicable Swiss medic requirements.
• Strong knowledge of eCTD dossier requirements and relevant ICH guidelines.
• Experience preparing and reviewing clinical and non‑clinical regulatory documentation.
• Experience with product information, patient information, labelling and packaging requirements.
• Knowledge of Swiss requirements governing medicinal product…