Clinical-Stage Biotech | Bay Area | Hybrid (2-days on-site)

Proclinical is partnering with a rapidly growing clinical-stage company advancing a high-potential pipeline in the immunology space. With multiple assets in mid-stage development, they're looking to bring on a Senior Regulatory Affairs Leader to drive global strategy across a dynamic portfolio.

Key Responsibilities:

This is a pivotal leadership role shaping regulatory direction across early- and mid-stage programs. Ideal for someone who's led U.S. and EU interactions, thrives in dynamic, cross-functional teams, and brings both strategic depth and executional precision.

What You'll Do:

Serve as the global regulatory lead across key development programsDevelop and execute comprehensive global regulatory strategiesCollaborate cross-functionally with CMC, Clinical, and Executive teamsLead submission readiness and agency interactions across programs

What You'll Bring:

10+ years of Regulatory Affairs experience in development-stage biotechProven track record leading global strategy (INDs, CTAs, NDAs, BLAs, MAAs); strong agency engagement (FDA & ex-U.S.)Excellent communication and leadership skills; confident interfacing with the C-Suite

Compensation:

$250,000 to $275,000 per annum.

If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at n.walker@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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