Senior Manager Regulatory Affairs

Senior Manager Regulatory Affairs at Warman O'Brien Senior Manager Regulatory Affairs at Warman O'Brien in Millbrae, California Posted in 6 days ago.

Type:

full-time

Job Description:

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.