Responsable affaires réglementaires

GALSER SA; Neuenburg; Vor Ort; CHF 130.000 - 170.000; Vollzeit

Zusammenfassung

GALSER SA in Neuchâtel, Switzerland is seeking an experienced Regulatory Affairs Manager with extensive hands-on knowledge of Swiss pharmaceutical regulations to lead submissions, lifecycle management and regulatory strategy for medicinal products. The role requires autonomy, pragmatism and the ability to interact directly with Swissmedic from strategy through approval.

You will coordinate with Medical, Quality and Commercial teams, maintain Swiss eCTD dossiers, and ensure compliance with Swiss

Qualifikationen

• Master’s degree in Life Sciences, Pharmacy or related field.
• 8+ years of experience in pharmaceutical Regulatory Affairs.
• Experience with Swiss marketing authorisation procedures.
• Hands-on experience with Swissmedic interactions and approvals.
• Strong knowledge of eCTD dossiers and ICH guidelines.

Aufgaben

• Prepare and manage marketing authorisation applications for human medicinal products in Switzerland.
• Oversee lifecycle management including variations, renewals and post-approval activities.
• Develop regulatory strategies for new and existing products and select Swiss pathways.
• Maintain Swiss eCTD dossiers and regulatory documentation.
• Interact directly with Swissmedic and respond to authority questions.
• Prepare and maintain product information, labeling and packaging texts.
• Ensure compliance with Swiss laws and Swissmedic guidance.
• Collaborate with Medical, Quality, Pharmacovigilance and Commercial teams.

Kenntnisse

Swiss Regulatory Affairs

Swissmedic interactions

Regulatory submissions

eCTD dossier knowledge

Lifecycle management

Regulatory strategy

Ausbildung

Master’s degree in Life Sciences or Pharmacy

Jobbeschreibung

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)

About the Role

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 Swissmedic.

Key Responsibilities

• 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 Swissmedic, 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 Swissmedic 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, RefData, and maintain appropriate regulatory tracking and documentation.

Requirements

• 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 Swissmedic and managing regulatory authority questions through to resolution.
• In‑depth knowledge of the regulatory framework governing medicinal product authorisation in Switzerland and applicable Swissmedic 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 advertising and promotional activities.
• Ability to interpret regulatory requirements and translate them into practical and efficient solutions.
• Proven ability to manage several regulatory projects simultaneously, establish priorities and work independently with minimal supervision.
• Strong analytical, organisational and problem‑solving skills.
• Excellent written and verbal communication skills.
• Proactive, detail‑oriented and solution‑driven approach.

A Plus

• Knowledge of EU regulatory procedures.
• Familiarity with international marketing authorisation procedures, including the UK, Singapore, Australia and/or Canada.
• Experience in Swiss Market Access, including reimbursement procedures, pricing, inclusion in the Spezialitätenliste (SL) and interactions with the Federal Office of Public Health (FOPH/BAG/OFSP).
• Experience in the CRO environment.
• Experience in Pharmacovigilance / Drug Safety.
• Other languages: e.g. Italian