Vice President, Regulatory Strategy Diligence

Travere Therapeutics • San Diego, CA

12d • $285,000 - $385,000 • Remote

About The Position

Travere Therapeutics is seeking a Vice President, Regulatory Strategy Diligence to lead the Regulatory Due Diligence team and regulatory strategy assessments for clinical- and commercial-stage assets involved in external business development opportunities. The role evaluates potential licensing, acquisition, partnership, and external innovation opportunities, identifying material technical risks and practical mitigations across asset development, including endpoints, development paths, milestones, phase-appropriate readiness, manufacturing, supply chain, and commercial readiness.

The position works closely with Business Development and leaders across Non-clinical, Clinical, Commercial, Legal, Regulatory, Technical Operations, and Quality to inform transaction decisions and post-deal integration planning. The successful candidate integrates Nonclinical, Clinical, and Regulatory CMC considerations into business development strategy and translates complex technical findings into clear executive-level recommendations. The role requires deep regulatory development expertise across small molecules, biologics (including gene therapy), ATMPs, and Companion Diagnostics, sound business judgment, and experience in confidential transaction environments.

This position is listed as remote, but all roles require the ability to perform face-to-face work with colleagues and/or onsite in San Diego; no role is expected to be 100% remote. Travel of 10–20% domestically and internationally is required.

Requirements

• Master’s or PhD in pharmaceutical sciences, biological sciences, engineering, chemistry, chemical engineering, or a related scientific discipline; an equivalent combination of education and applicable job experience may be considered.
• 15 or more years of relevant pharmaceutical or biotechnology industry experience in regulatory and pharmaceutical development with a Business Development focus, including clinical, manufacturing and technical operations, process, or related functions.
• Eight years of previous people-management and leadership experience.
• Experience in a similar strategic management position with significant interaction with executive leadership.
• Professional experience in a similar role within the biotech or pharmaceutical industry.
• Strong understanding of GMP requirements, regulatory expectations and guidance, clinical trial design, statistics and process validation, analytical development, technology transfer, and product lifecycle management.
• Demonstrated experience leading or contributing to due diligence, asset evaluations, licensing, acquisitions, partnerships, or external alliance assessments.
• Ability to synthesize and communicate complex regulatory and technical information as clear risks, recommendations, timelines, and mitigation plans to internal and external audiences, including senior management.
• Excellent communication and influencing skills.
• Ability to build strong partnerships across internal functions and with external partners, consultants, CROs, CDMOs, and subject-matter experts.
• Ability to operate effectively in a fast-paced, confidential, matrixed environment with shifting priorities and compressed timelines.
• Strong interpersonal, organizational, verbal communication, written communication, decision-making, and collaboration skills, with attention to detail.
• Ability to perform face-to-face work with colleagues and/or onsite in San Diego.
• Ability to travel 10–20% domestically and internationally.

Nice To Haves

• Experience progressing late-stage assets from clinical development through commercialization.
• Experience supporting both biologics and small-molecule development and commercialization.
• Rare disease, orphan drug development, global supply, regulatory submission, or post-deal integration experience.

Responsibilities

• Lead regulatory due diligence for licensing, acquisition, partnership, and external innovation opportunities by assessing readiness risks for clinical- and commercial-stage assets.
• Evaluate drug and device regulatory development, including product development, pediatrics, regulatory strategies, agency feedback, risks and mitigations, timelines, and development strategies.
• Own integrated regulatory risk assessments and recommendations for opportunities; identify and champion risk-mitigation activities, distinguish transaction-critical issues, and communicate assumptions, dependencies, timeline effects, and proposed mitigations.
• Evaluate CMC drug substance and product manufacturing, product development, control strategies, analytical work, validation, stability, technology transfer, and lifecycle management plans.
• Review regulatory aspects of CRO and CMO capabilities, capacity, compliance history, performance, network redundancy, supply continuity, and readiness to support clinical or commercial supply.
• Partner with stakeholders across Business Development, Corporate Strategy, Non-clinical, Clinical, Pharmacovigilance, Quality, Regulatory, Finance, Legal, Program Management, and Technical Operations.
• Prepare timely, concise diligence reports, risk registers, executive presentations, and post-transaction recommendations.
• Lead regulatory, documentation, and technical input into term sheets, definitive agreements, quality agreements, supply agreements, transition plans, and joint collaboration governance.
• Establish enterprise regulatory diligence strategy, standards, tools, templates, and risk frameworks.
• Advise leadership on regulatory considerations for strategic transactions.
• Contribute to continuous improvement of diligence tools, templates, risk frameworks, and evaluation standards.
• Perform additional duties as assigned.

Benefits

• Premium health, financial, work-life, and well-being offerings for eligible employees and dependents.
• Wellness and employee support programs.
• Life insurance and disability coverage.
• Retirement plans with employer match.
• Generous paid time off.
• Base pay and short-term incentive compensation.
• Long-term incentive compensation in company stock.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive