Vice President, Regulatory Strategy Diligence Greater San Diego, CA Area

The Company is seeking a Vice President of Regulatory Strategy Diligence to lead regulatory assessments of clinical- and commercial-stage assets considered for licensing, acquisitions, partnerships, and other external opportunities. The role involves identifying material development and regulatory risks, recommending practical mitigations, and integrating regulatory considerations into transaction decisions and post-deal planning. Responsibilities include evaluating development strategies, agency feedback, manufacturing and supply readiness, and regulatory capabilities; partnering with cross-functional stakeholders; and preparing diligence reports, risk assessments, and executive recommendations. The successful candidate will also guide regulatory input into transaction and collaboration agreements and establish diligence standards, tools, and frameworks. Candidates must have a master’s degree or PhD in a relevant scientific or engineering discipline, or an equivalent combination of education and experience, along with at least 15 years of relevant pharmaceutical or biotechnology experience and eight years of people-management and leadership experience. Extensive regulatory and pharmaceutical development expertise, including business development diligence and asset evaluation, is required; experience with both biologics and small molecules is preferred. Candidates should understand GMP requirements, clinical development, CMC, manufacturing, technology transfer, and product lifecycle management. Strong executive communication, sound business judgment, and the ability to translate complex technical findings into clear risks, recommendations, timelines, and mitigation plans are essential.

Hiring Company

Travere Therapeutics