Regulatory Affairs Consultant

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.

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

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

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