Director / Senior Director, Regulatory Strategy
Director / Senior Director, Regulatory Strategy Clinical-stage biotech | San Francisco Bay Area | Hybrid
We're partnering with an innovative clinical-stage biotech that is advancing novel biologic therapies in areas of high unmet need. As the pipeline progresses through the clinic, the company is looking for a strategic, hands-on regulatory leader to shape and drive global development strategy. The title will depend on experience.
The opportunity
- Lead global regulatory strategy for one or more clinical programs, from early development through later-stage planning
- Act as a key regulatory point of contact with FDA and other health authorities
- Lead the strategy and preparation for health authority interactions, INDs, CTAs and key submissions
- Partner closely with clinical, CMC, nonclinical and program leadership as a core member of development teams
- Shape regulatory pathways, including expedited programs, as assets progress
The profile
- Advanced scientific degree preferred, with progressive regulatory strategy experience in biotech or pharma
- Direct experience leading health authority interactions
- Background in biologics and immunology or oncology strongly preferred
- Thrives in a lean, collaborative environment and is comfortable balancing strategy with execution
- Clear communicator who can influence cross-functional and executive stakeholders
Why consider
- High-visibility role with real influence on pipeline direction
- Innovative science with meaningful patient impact
- Collaborative, scientifically driven culture
For a confidential conversation, reach out to Sydney Hewitt at EPM Scientific - sydney.hewitt@epmscientific.com
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