Senior Regulatory Affairs Consultant

Job Title: Senior Associate Regulatory Affairs Consultant

Location: Basel, Switzerland

Working Arrangement: Hybrid – 1–2 days per week in the Basel office

Contract Type: Freelance / Independent Consultancy (FTE)

Start Date: December 2026

Workload: Up to 150 hours per month

Company overview:

Apsida Life Science is partnering with a leading global contract research organisation that partners with pharmaceutical, biotechnology, and medical device companies to accelerate the development and delivery of innovative therapies. With decades of industry experience and a global presence, the organisation provides expertise in clinical development, regulatory consulting, market access, and real-world evidence to help bring new treatments to patients worldwide.

Key Responsibilities:

• Develop, contribute to and review regulatory submission content and formatting in accordance with Swiss regulatory guidelines.
• Support the preparation and coordination of major and minor regulatory submissions, PSURs, labelling changes, CMC variations, post-approval commitments, notifications and other regulatory activities.
• Contribute to the development and execution of regulatory strategies across clinical development, post-marketing activities and lifecycle management.
• Collaborate with Swiss regulatory teams, Global Regulatory Science, Regulatory CMC and global cross-functional project teams.
• Maintain Swiss product labelling, including SmPC, PIL, artwork and packaging in local languages, ensuring alignment with regulatory requirements and global labelling/core data sheets.
• Coordinate regulatory submission activities for assigned projects and programmes.
• Support the Head of Regulatory Switzerland with regulatory activities as required.
• Proactively identify regulatory challenges and develop compliant solutions.

Requirements:

• Degree in Life Sciences or a related discipline. An advanced degree (PharmD, MSc or PhD) is preferred.
• 5–8+ years of experience in Regulatory Affairs or a related field.
• Strong knowledge of current Swissmedic regulations and regulatory requirements.
• Demonstrated experience preparing major regulatory submissions and variation packages for Swissmedic.
• Strong experience with CTD format and eCTD submission builds, including preparation of Swiss Module 1 documentation.
• Hands-on experience with TPA Article 13 procedures, including Marketing Authorisation Applications (MAAs) and post-approval variations.
• Experience with EMA or other international regulatory processes is advantageous.
• Experience in biologics and vaccines is preferred. Exposure to rare diseases, autoimmune diseases or oncology is beneficial.
• Excellent written and spoken German and English are essential.
• French language skills are required, while Italian is advantageous.
• Strong operational experience managing Swissmedic regulatory activities independently.

If you are interested in learning more, please reach out to KG Mphahlele at Apsida Life Science:

kgmphahlele@apsida.com

+44 744 134 1041

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.