Director / Senior Director, Regulatory Strategy

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