Vice President Regulatory Affairs

Executive Recruit; Durham (NC); On-site; USD 260,000 - 340,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Regulatory strategy leadership

Quality systems

GxP compliance

Biotech/pharma regulatory

Health authority meetings

CMC strategy

Team leadership

Education

Bachelor's degree in a scientific field

Job description

My client, clinical-stage biopharmaceutical company, is seeking a senior regulatory and compliance leader to build and lead its regulatory strategy and quality systems as the company moves toward late-stage development and initial marketing applications. The lead program uses a novel mechanism with limited regulatory precedent, so this leader will help define the regulatory path rather than follow an established one. The role also requires practical ownership of quality systems and GxP compliance in a small, outsourced operating model.

Responsibilities

• Own end-to-end regulatory strategy from preclinical development through marketing application, including clinical trial applications, lifecycle management, labeling, pediatric planning, and ex-U.S. strategy.
• Serve as the primary interface with U.S. and international health authorities, including formal advice meetings and late-stage milestone meetings.
• Build and defend the scientific and regulatory case for a novel mechanism, including alignment on late-stage endpoints, patient population, and dosing.
• Own CMC regulatory strategy for an engineered protein therapeutic, including comparability, immunogenicity, and oversight of contract manufacturing partners.
• Establish safety governance and pharmacovigilance, including safety reporting, periodic safety reports, and regulatory interface with the data monitoring committee.
• Set quality strategy and GxP compliance across GCP, GLP, and GMP, with emphasis on clinical data integrity and computerized system validation.
• Lead inspection readiness, vendor quality oversight, and executive escalation for significant quality issues and corrective actions.
• Oversee outsourced regulatory support and report quality metrics and risks to the CEO and Board.
• Build the function over time, beginning with defining and hiring a Director-level regulatory leader.

Required Experience

• 12+ years of progressive regulatory strategy and/or quality experience in biotechnology or pharmaceuticals, including team-building and leadership.
• Experience advancing a product with limited regulatory precedent through a major health authority, including resolving a substantive scientific disagreement with a review division.
• Hands-on experience with investigational applications and direct leadership of health-authority meetings, including at least one late-stage milestone interaction.
• Biologic or complex-modality experience, including CMC strategy, comparability, and immunogenicity.
• A track record of building a regulatory and/or quality function at a small or early-stage company, including hiring and managing quality leaders.
• Working knowledge of GCP, GLP, and GMP sufficient to set strategy and oversee hands-on quality staff.
• Experience working within an outsourced clinical monitoring model.
• Bachelor’s degree required; advanced degree preferred.

Preferred Experience

• Rare disease or endocrine/metabolic development experience.
• Clinical data integrity and computerized system validation experience in outpatient trials.
• Experience at a company preparing for public-company readiness.
• Regulatory Affairs Certification or equivalent.