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 programs
- Develop and execute comprehensive global regulatory strategies
- Collaborate cross-functionally with CMC, Clinical, and Executive teams
- Lead submission readiness and agency interactions across programs
What You'll Bring:
- 10+ years of Regulatory Affairs experience in development-stage biotech
- Proven 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.
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