Senior VP, Regulatory Strategy & Quality - Biotech

Executive Recruit; Durham (NC); Sur place; USD 260 000 - 340 000; Plein temps

Résumé du poste

Executive Recruit's client, a clinical-stage biopharmaceutical company, seeks a senior regulatory and compliance leader to define regulatory strategy and quality systems as it advances toward late-stage development and initial marketing applications. This role owns end-to-end regulatory strategy and interfaces with health authorities while overseeing CMC and safety governance.

The candidate will build the function, lead an outsourced operating model, and hire a Director-level regulatory leader

Qualifications

• 12+ years in regulatory strategy and/or quality leadership in biotech or pharma.
• Experience moving a product with limited precedent through a major health authority.
• Hands-on investigator applications and leadership of health-authority meetings.
• Biologic or complex-modality experience including CMC strategy and immunogenicity.
• Track record of building regulatory/quality functions at small or early-stage companies.
• Working knowledge of GCP, GLP, and GMP.
• Experience in an outsourced clinical monitoring model.
• Bachelor’s degree required; advanced degree preferred.

Responsabilités

• Own end-to-end regulatory strategy from preclinical through marketing application.
• Interface with U.S. and international health authorities for advice and milestone meetings.
• Build and defend the regulatory case for a novel mechanism.
• Own CMC regulatory strategy including comparability and immunogenicity.
• Establish safety governance and pharmacovigilance with data monitoring committee interfaces.
• Set quality strategy and GxP compliance across GCP, GLP, and GMP.
• Lead inspection readiness and vendor quality oversight.
• Oversee outsourced regulatory support and report metrics to CEO and Board.
• Define and hire a Director-level regulatory leader to begin building the function.

Connaissances

Regulatory strategy leadership

Quality systems

GxP compliance

Biotech/pharma regulatory

Health authority meetings

CMC strategy

Team leadership

Formation

Bachelor's degree in a scientific field

Description du poste

Executive Recruit's client, a clinical-stage biopharmaceutical company, seeks a senior regulatory and compliance leader to define regulatory strategy and quality systems as it advances toward late-stage development and initial marketing applications. This role owns end-to-end regulatory strategy and interfaces with health authorities while overseeing CMC and safety governance.

The candidate will build the function, lead an outsourced operating model, and hire a Director-level regulatory leader