Vice President Clinical Regulatory Affairs

I am conducting a retained search for a Vice President, Global Regulatory & Clinical Strategy on behalf of a commercial-stage biotech with a growing pipeline spanning small molecules, biologics, and gene therapy.

This is a highly visible global leadership role reporting directly to the SVP, Regulatory Affairs, with regular executive exposure and a clear succession path into broader regulatory leadership. The opportunity combines organizational stability, pipeline momentum, and genuine leadership scope at a commercial-stage market leader with a well-defined long-term growth strategy.

Responsibilities:

• Develop and oversee the execution of clinical regulatory affairs strategies to shorten approval times and improve product labeling in the US and other regions.
• Hire, train, and lead a team of clinical regulatory strategy professionals.
• Oversee the assembly of regulatory packages for IND, CTA, NDA/BLA, and MAA submissions for new product development.
• In partnership with the VP of Regulatory CMC, oversee the management of marketed products, ensuring all reporting obligations are met, including PSURs and annual reports to both FDA and ex-US regulatory bodies.
• Lead the regulatory function in strategizing and executing clinical trial programs for sNDAs for the company’s lead product.
• Collaborate with partners in support of ex-US regulatory filings for products.
• Consult with domestic and international regulatory agencies. Represent the company in regulatory health authority meetings. Assist with preparing Type B or C meeting documents, meeting requests, meeting packages, etc.
• Provide leadership on regulatory interactions with and presentations to regulatory agencies, customers, and partners.
• Collaborate closely with members of the Regulatory Affairs, Clinical, Medical, Pharmacovigilance, Quality, Commercial, and Legal/Compliance Departments.
• Oversight of PADERS, PSURs, DSURs, and other reports to global regulatory authorities.
• Review and approval of Study Protocols, Clinical Study Reports, Statistical Analysis Plans, ISE, ISS, Module documents, and other documentation to be submitted to US and ex-US health authorities.
• Interpret regulatory guidance and provide recommendations to key stakeholders. Remain current and coach the regulatory group on regulatory guidance documents from the FDA, EMA, ICH, etc.
• Ensure adherence to relevant regulatory guidance and company Standard Operating Procedures (SOPs).
• Function as a responsible company contact during inspections by the FDA and other authorities.

Education and Experience:

• Bachelor’s degree in a relevant scientific field is required. Advanced degrees, such as PhD, MD, or PharmD, are preferred.
• 15 years of industry experience, including 10 or more years in Regulatory Affairs for pharmaceutical and biological products, is required.
• Previous experience hiring, leading, and managing a Regulatory team is required.
• Demonstrated experience working directly with FDA and other global Health Authorities (EMA, Health Canada, PMDA, etc.) is required.
• Strong knowledge of drug, biological, development, and regulatory policy.
• Experience developing and leading regulatory strategies for INDs, CTAs, NDAs, BLAs, MAAs, IDEs.
• Strong knowledge of biopharmaceutical industry Regulatory Affairs throughout the product lifecycle, including Development, CMC, Labeling, Promotion, Commercialization, and Operations.
• Knowledge of clinical development, including responsibilities for successful management of development milestones and marketing authorization, meeting facilitation, and regulatory responses.
• Demonstrated knowledge of global (US, EU/UK, and ICH) regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues.