Vice President, Regulatory Strategy Diligence

Travere • San Diego, CA

9d • $285,000 - $385,000 • Remote

About The Position

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

The Vice President works closely with Business Development and leaders across Non-clinical, Clinical, Commercial, Legal, Regulatory, Technical Operations, Quality, and other functions. The role integrates regulatory considerations for Nonclinical, Clinical, and Regulatory CMC into business development strategy and supports informed transaction and investment decisions, as well as post-deal integration planning. The successful candidate brings deep regulatory development expertise across small molecules, biologics (including gene therapy), ATMPs, and Companion Diagnostics; sound business judgment; experience in confidential transaction environments; and the ability to translate complex technical findings into clear executive-level recommendations.

The position is based in San Diego and is described as remote, but all positions 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 degree 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.
• At least 15 years of relevant experience in the pharmaceutical or biotechnology industries, including regulatory and pharmaceutical development experience with a Business Development focus and experience in clinical, manufacturing and technical operations, process, or related functions.
• At least 8 years of 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, preferably supporting both biologics and small-molecule development and commercialization.
• 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, and written communication skills; strong decision-making and collaboration skills; and 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 with rare disease or orphan drug development, global supply, regulatory submissions, or post-deal integration.
• Experience supporting both biologics and small-molecule development and commercialization.
• The ideal candidate embodies Travere’s core values of Courage, Community Spirit, Patient Focus, and Teamwork; is driven, intelligent, and passionate about making a difference for patients with rare diseases; and is a team player.

Responsibilities

• Lead regulatory due diligence for licensing, acquisition, partnership, and external innovation opportunities, assessing readiness risks for clinical- and commercial-stage assets.
• Evaluate drug and device regulatory development, including product development, pediatrics, regulatory strategies, agency feedback, risks, mitigations, timelines, and development strategies.
• Own the integrated regulatory risk assessment and recommendation for each opportunity; identify and champion risk-mitigation activities, distinguish transaction-critical issues, and communicate assumptions, dependencies, potential 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 Business Development, Corporate Strategy, Non-clinical, Clinical, Pharmacovigilance, Quality, Regulatory, Finance, Legal, Program Management, and Technical Operations stakeholders.
• 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.
• Disability benefits.
• Retirement plans with employer match.
• Generous paid time off.
• Cash compensation comprising base pay and a short-term incentive.
• Long-term incentive compensation in the form of company stock.

What This Job Offers

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