Regulatory Affairs Consultant

The Company

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

• Influence early-stage development strategy

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

• Potential for long-term collaboration as the project grows

  
  

To apply please email your CV to recruitment@consultantsinscience.com