Senior Vice President, Regulatory Innovation and Policy

ProPharma • Washington, DC

1d • Hybrid

About The Position

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Responsibilities

• Regulatory Strategy and Leadership: Serve as lead regulatory strategist and scientific authority for client engagements across therapeutic areas, including rare diseases. Develop and execute comprehensive regulatory strategies for IND, NDA, and BLA programs, including biosimilar and gene-therapy submissions. Advise on clinical development plans, study designs, endpoints, and risk-benefit assessments aligned with FDA expectations and evolving regulatory science. Prepare and lead high-stakes FDA interactions (Pre-IND, Type B/C, End-of-Phase, and pre-BLA/NDA meetings). Author, review and approve major client deliverables such as briefing books, regulatory correspondence, and submission modules to ensure technical accuracy and strategic alignment.
• Client and Program Oversight: Lead multidisciplinary teams to design and execute regulatory and clinical strategies that support client objectives. Serve as senior author / reviewer and signatory for key deliverables (briefing documents, IND/BLA modules, regulatory correspondence). Represent clients at FDA, EMA, and international regulatory meetings as senior medical authority.
• Client Engagement and Advisory Excellence: Act as senior relationship lead for key client accounts, ensuring quality, timeliness, and strategic impact of consulting deliverables. Translate complex regulatory expectations into clear, actionable development pathways for sponsors. Represent the firm in FDA, EMA, and other agency meetings, serving as a credible, authoritative medical voice. Provide proactive regulatory intelligence to clients, anticipating shifts in agency policy and emerging scientific trends.
• Internal Leadership and Mentorship: Mentor and develop consultants, regulatory scientists, and project leaders in regulatory and clinical best practices. Lead internal training on FDA processes, submission standards, and scientific review methodologies. Foster collaboration across multidisciplinary consulting teams to ensure consistent delivery excellence. Contribute to internal white papers, thought leadership, and regulatory science publications.
• Corporate and Business Development Support: Partner with Business Development to identify, scope, and win new client engagements. Participate in client proposal development, capability presentations, and scientific advisory sessions. Support firm visibility through speaking engagements, conferences, and authored content highlighting the firm’s regulatory expertise.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: No Education Listed
• Number of Employees: 501-1,000 employees