Regulatory Affairs Consultant

Consultants in Science Sàrl; Suisse; À distance; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A biotech consultancy in Switzerland is seeking a seasoned Regulatory Affairs Consultant to shape and drive regulatory strategy across US and EU markets. The ideal candidate will have over 8 years of experience in regulatory affairs within biotech or pharma, proven success with FDA and EMA submissions, and a strategic mindset. This flexible role includes working remotely with minimal travel and offers potential for long-term collaboration as the project evolves.

Prestations

Flexible working hours

Remote-friendly role

Potential for long-term collaboration

Qualifications

• 8+ years of Regulatory Affairs experience in biotech/pharma.
• Proven success with FDA and EMA submissions.
• Experience in biologics development and submissions.

Responsabilités

• Shape regulatory strategy for preclinical and early clinical development.
• Prepare for IND/IMPD submissions.
• Lead health authority interactions (FDA, EMA).
• Conduct regulatory gap analyses and review the Target Product Profile.

Connaissances

Regulatory Affairs experience

FDA submissions experience

EMA submissions experience

Strategic mindset

Ability to thrive in a start-up environment

Description du poste

We’re partnering with an early‑stage biotech company developing a novel therapeutic candidate. As they approach critical preclinical and regulatory milestones, they are seeking a seasoned Regulatory Affairs Consultant to shape and drive their regulatory strategy across both the US and EU markets.

The role

You’ll serve as the company’s go‑to regulatory expert, providing high‑level guidance and hands‑on support. This includes:

• Shaping regulatory strategy for preclinical and early clinical development
• Preparing for IND/IMPD submissions
• Leading health authority interactions (FDA, EMA)
• Conducting regulatory gap analyses and reviewing the Target Product Profile (TPP)
• Supporting CMC‑related documentation and regulatory planning

What We're Looking For

• 8+ years of Regulatory Affairs experience in biotech/pharma
• Proven success with FDA and EMA submissions
• Experience in biologics development and submissions (IND/IMPD, Orphan Designation, Scientific Advice, etc.)
• Ability to thrive in a dynamic start‑up environment
• Strategic mindset with flexibility to scale involvement as needs evolve
• Must be resident in Switzerland and authorized to work in Switzerland

Why Apply?

Join a cutting‑edge biotech with real potential

Flexible, remote‑friendly role with minimal travel (monthly in‑person meetings at Biopôle)

Potential for long‑term collaboration as the project grows