Vice President 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. #J-18808-Ljbffr Kaye/Bassman International