Director / Senior Director, Regulatory Strategy

EPM Scientific; San Francisco (CA); Ibrido; USD 180.000 - 250.000; Tempo pieno

Descrizione del lavoro

EPM Scientific in the San Francisco Bay Area partners with a clinical-stage biotech seeking a Director/Senior Director of Regulatory Strategy to shape global development plans. This hands-on, strategic role operates in a lean, collaborative environment with high visibility.

The candidate will lead regulatory strategy across programs, interact with FDA and other authorities, and drive major submissions, including expedited pathways where appropriate.

Competenze

• Advanced scientific degree in biotech/pharma or related field.
• Progressive regulatory strategy experience in biotech or pharma.
• Experience leading health authority interactions.

Mansioni

• Lead global regulatory strategy for one or more clinical programs through development.
• Serve as regulatory lead with FDA and other health authorities.
• Direct strategy and preparation for health authority meetings, INDs, CTAs, and major submissions.
• Collaborate with clinical, CMC, nonclinical and program teams to drive development plans.
• Influence regulatory pathways, including expedited programs, as assets progress.

Conoscenze

Regulatory strategy

Health authority interactions

Biologics/Immunology

Formazione

Advanced scientific degree

Descrizione del lavoro

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