Global Regulatory Strategy Director - Biotech, Hybrid

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

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.