* Jo
* Jun 2
* 1 min read
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
Tags
* regulatory affairs
* Consultants
* Vacancies
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