Senior Vice President, Regulatory Innovation and Policy

Job description

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...