Senior Vice President, Regulatory Affairs & Quality Assurance

Senior Vice President, Regulatory Affairs & Quality Assurance

About the Company

Clinical-stage biotechnology company developing antifungal therapies and global registration-ready pipeline assets

Industry
Biotechnology

Type
Privately Held

About the Role

The Company is seeking a Senior Vice President of Regulatory Affairs and Quality Assurance to shape regulatory strategy and establish a quality foundation for clinical-stage development programs. The role will guide assets from Phase 2 through Phase 3, registration, and launch readiness, leading interactions with global health authorities and advising on approval pathways, labeling, and lifecycle planning. The executive will coordinate regulatory, quality, CMC, and operational strategies for major submissions, partnering with clinical, nonclinical, development, and external teams. They will also build and lead a scalable GxP quality management system, overseeing inspection readiness, audits, quality agreements, corrective and preventive actions, change control, and vendor quality. Candidates should have at least 15 years of progressive regulatory affairs and quality experience, including 10 or more years in executive leadership within biotechnology or biopharmaceutical organizations. A bachelor’s degree in a scientific discipline is required; an advanced degree is preferred. Required expertise includes global regulatory strategy, expedited approval pathways, health authority interactions, NDA and MAA submissions, quality systems development, and inspection readiness. Experience with government-funded programs, anti-infective or infectious disease products, and CMC regulatory affairs is preferred.

Hiring Manager Title
Chief Executive Officer

Functions

• Medical Care/Hospital Administration