Senior Manager Regulatory Affairs

Senior Manager, Regulatory Affairs

Clinical-Stage Precision Medicine Biotech | Bay Area

We’re supporting an innovative, clinical-stage biotech focused on translating human genetics into precision small-molecule therapies targeting renal, cardiovascular, and metabolic diseases.

This is an excellent opportunity for an experienced Regulatory Affairs professional seeking a highly visible, hands-on role with significant ownership across global development programs. The position offers close collaboration with Clinical, CMC, Biometrics, and executive leadership teams, alongside direct interaction with international Health Authorities.

The Opportunity

• Lead regulatory activities for designated clinical-stage programs
• Develop and execute global regulatory strategies
• Prepare and manage INDs, CTAs, amendments, and agency communications
• Partner cross-functionally to support program advancement and key milestones
• Contribute strategically within a collaborative, science-led environment

Ideal Background

• Approximately 7+ years of Regulatory Affairs experience within biotech or pharmaceutical environments
• Strong understanding of US and EU regulatory frameworks, including ICH guidelines
• Demonstrated experience authoring and managing IND/CTA submissions
• Background supporting clinical development programs preferred

What’s on Offer

• Base salary up to $220,000, depending on experience
• Annual bonus and equity participation
• Comprehensive healthcare coverage including medical, dental, and vision
• 401(k) with company match
• Generous PTO and holiday allowance

This is a fantastic opportunity to join a well-funded biotech with a growing pipeline and make a meaningful impact within a cutting-edge precision medicine environment.

If this opportunity could be of interest, please apply with a copy of your CV to arrange a confidential discussion.