Senior Manager Regulatory Affairs
$220kWarman O'Brien
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.
Vacancy posted 4 days ago
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