Senior Vice President, Regulatory Innovation and Policy

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.

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.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***