Regulatory Affairs Manager

Skills Alliance; Neuenburg; On-site; CHF 140,000 - 190,000; Full time

Job summary

Skills Alliance is supporting a pharmaceutical organisation in Switzerland by appointing an experienced Regulatory Affairs Manager to oversee regulatory submissions, marketing authorisations and lifecycle management for medicinal products in the Swiss market. The role requires hands-on leadership, extensive knowledge of Swissmedic requirements, eCTD dossiers, and proactive interaction with authorities.

You will guide strategy through approval and collaborate with Quality, Medical and Commercial

Qualifications

• Master's degree in Life Sciences, Pharmacy or related.
• 8+ years in pharmaceutical Regulatory Affairs.
• Expertise in Swiss marketing authorisation and lifecycle.
• Experience preparing submissions from strategy to approval.
• Proven interactions with Swissmedic and regulatory bodies.
• Strong knowledge of ICH guidelines and eCTD.

Responsibilities

• Lead preparation and submission of Swiss MA for human medicines.
• Manage full regulatory lifecycle including variations and renewals.
• Develop strategies for new and existing products for Swiss market.
• Prepare and review eCTD dossiers.
• Act as main contact with Swissmedic and respond to queries.
• Ensure labeling, patient information, and promotional materials comply.
• Monitor regulatory developments affecting products.

Skills

Regulatory strategy

Swissmedic liaison

eCTD submissions

Regulatory lifecycle mgmt

Cross-functional collaboration

Regulatory compliance

Education

Master's degree in Life Sciences/Pharmacy

Job description

We are supporting a pharmaceutical organisation in Switzerland in the appointment of an experienced Regulatory Affairs Manager to oversee regulatory submissions, marketing authorisations and lifecycle management for medicinal products within the Swiss market.

This is a hands-on position suited to a highly autonomous, pragmatic and commercially aware regulatory professional with extensive knowledge of Swissmedic requirements and Swiss pharmaceutical regulations.

The successful candidate will take ownership of regulatory activities from strategy through submission and approval, working closely with internal stakeholders and external regulatory authorities to ensure ongoing compliance and support product commercialisation.

Key Responsibilities

• Lead the preparation, compilation and submission of Swiss marketing authorisation applications for human medicinal products.
• Manage the full regulatory lifecycle of authorised products, including variations, renewals, notifications and post-approval activities.
• Develop and implement regulatory strategies for new and existing medicinal products, identifying appropriate Swiss regulatory pathways.
• Prepare, review and maintain eCTD dossiers, including clinical and non-clinical regulatory documentation.
• Act as a key point of contact with Swissmedic, managing regulatory correspondence, deficiency letters, authority questions and responses.
• Oversee Swiss product information, patient information, labelling, packaging texts and associated regulatory documentation.
• Ensure compliance with Swiss pharmaceutical legislation, Swissmedic guidance and relevant ICH guidelines.
• Monitor regulatory developments and assess their impact on existing products and future submissions.
• Review advertising, promotional materials, HCP communications and digital content to ensure compliance with Swiss pharmaceutical advertising requirements.
• Provide regulatory guidance to Medical, Commercial and Marketing teams.
• Support regulatory activities associated with product launches and commercialisation in Switzerland.
• Collaborate with Quality, Pharmacovigilance, Medical, Commercial, external manufacturers, suppliers and strategic partners.
• Maintain regulatory information systems, submission trackers and relevant regulatory documentation.

Candidate Requirements

• Master's degree in Life Sciences, Pharmacy or a related scientific discipline.
• Minimum 8 years of experience in pharmaceutical Regulatory Affairs, with substantial hands-on experience in the Swiss market.
• Proven expertise in Swiss marketing authorisation procedures and lifecycle management for human medicinal products.
• Demonstrated experience preparing and managing regulatory submissions from initial strategy through approval.
• Direct experience interacting with Swissmedic, including responding to authority questions and resolving regulatory deficiencies.
• Strong understanding of Swiss pharmaceutical legislation, regulatory pathways and Swissmedic requirements.
• Excellent knowledge of eCTD submissions, ICH guidelines and regulatory dossier preparation.
• Experience reviewing clinical and non-clinical documentation, product information, labelling and packaging.
• Understanding of Swiss regulations governing pharmaceutical advertising and promotional activities.
• Ability to independently manage multiple regulatory projects and competing priorities.
• Strong analytical, organisational and stakeholder management skills.
• Proactive, detail-oriented and solutions-focused approach.