Head of Regulatory Affairs – Scaling Biotech

VP / Head of Regulatory Affairs – Biotechnology

Location: Western-Switzerland

Contract: Permanent | Full-Time

Industry: Biotechnology

The Opportunity

We are working with an innovative biotechnology company seeking an experienced VP / Head of Regulatory Affairs to join its senior leadership team.

The organisation is progressing through an important phase of clinical development and is looking for a strategic, hands-on regulatory leader to take ownership of global regulatory activities.

This position offers significant autonomy, international exposure and the opportunity to play a central role in the development and registration of innovative therapeutics.

Key Responsibilities

• Define and execute global regulatory strategies, with a focus on US and European markets.
• Lead regulatory planning and execution for late-stage clinical development and marketing authorisation submissions.
• Manage interactions with international regulatory authorities, including the FDA and EMA.
• Provide regulatory guidance across clinical development, CMC and cross-functional programmes.
• Oversee submission preparation, regulatory documentation and health authority responses.
• Advise senior management on regulatory risks, strategic decisions and development priorities.
• Coordinate external regulatory partners and support the development of internal regulatory capabilities.

Your Profile

• 10+ years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
• Proven involvement in late-stage clinical development and major regulatory submissions, ideally including a BLA or NDA.
• Strong experience with biologics or other complex therapeutic products.
• Demonstrated experience engaging directly with the FDA and EMA.
• Experience in rare disease or orphan drug development is required.
• Broad understanding of regulatory CMC, clinical development and registration requirements.
• Ability to operate strategically while remaining hands-on in a dynamic biotechnology environment.
• Excellent communication and stakeholder management skills.

What’s on Offer?

• A senior leadership position with significant strategic responsibility.
• The opportunity to lead global regulatory activities during an important development phase.
• A dynamic biotechnology environment offering autonomy and direct influence on key decisions.
• International exposure and close collaboration with senior management.
• The opportunity to contribute to the advancement of innovative therapeutic programmes.

Interested?

If you have extensive regulatory leadership experience and are looking for an opportunity to make a meaningful impact within an innovative biotechnology organisation, I would be pleased to discuss this position confidentially.

Apply now or contact me directly for further information.