Senior Regulatory Affairs Expert — Companion Diagnostics (CDx) & Precision Medicine

Shape the regulatory strategy of a next-generation precision medicine platform, from the inside of an ambitious early-stage biotech.

Engagement

Fractional / Contract

Location

Remote or Hybrid

Seniority

Senior / Executive

Domain

Companion Diagnostics

About the opportunity

An innovative early-stage biotechnology company is seeking an experienced Senior Regulatory Affairs Consultant (Fractional) to lead and shape the regulatory strategy for companion diagnostics (CDx).

We are looking for a highly experienced regulatory professional with a proven track record in early-stage biotech companies and companion diagnostics. The ideal candidate has successfully developed regulatory strategies for CDx and has hands-on experience navigating both US and European regulatory pathways while supporting drug development programs.

This is a high-impact strategic role where your expertise will directly influence product development, regulatory planning, and future commercialization.

Required experience

Extensive experience in Regulatory Affairs within biotechnology or diagnostics
Strong Companion Diagnostics (CDx) expertise
Experience working in startup or early-stage biotech companies
Hands-on with FDA PMA, IDE, Q-Submissions and 510(k)
Practical experience with European IVDR
Supporting diagnostic products alongside pharmaceutical development
Strategic regulatory planning
Cross-functional collaboration with R&D, Clinical, Quality and Executive teams

Preferred qualifications

Precision Medicine experience
Biomarker development experience
In Vitro Diagnostics (IVD) expertise
Excellent communication and leadership skills
Ability to work independently in a fast-moving innovation environment

Ready to lead the regulatory strategy?

If you have significant experience leading Companion Diagnostic regulatory strategies and would like to contribute to an exciting early-stage biotech journey, we would love to hear from you.