VP, Regulatory Diligence & Strategy (M&A)

Travere Therapeutics; Wichita (KS); On-site; USD 285,000 - 385,000; Full time

Benefits offered by this job

Premium health

Financial benefits

Work-life balance

Retirement plan

Paid time off

Stock options

Job summary

Travere Therapeutics in San Diego is seeking a Vice President, Regulatory Strategy Diligence to lead regulatory due diligence for external business opportunities, assessing risks across clinical, manufacturing, and regulatory readiness.

The role requires 15+ years in pharma/biotech with regulatory and business development focus, strong leadership, and ability to translate complex regulatory findings into executive recommendations. Travel 10–20% domestically and internationally.

Qualifications

• 15+ years in pharma/biotech with regulatory and business development focus.
• Experience with biologics, small molecules, and gene therapy.
• Proven leadership of teams and integration of regulatory risk into strategy.
• Strong communication of complex regulatory issues to executives.

Responsibilities

• Lead regulatory due diligence for licensing, acquisition, partnership, and external innovation opportunities by assessing readiness risks for clinical/commercial-stage assets.
• Evaluate drug/device regulatory development including all levels of product development, pediatrics, regulatory strategies, agency feedback, risks and mitigations, timelines and development strategies.
• Own the integrated regulatory risk assessment and recommendation for each opportunity, identify and champion mitigation activities.
• Evaluate CMC drug substance/product manufacturing, product development, control strategies, analytical, validation, stability, technology transfer, and lifecycle management plans.
• Review regulatory aspects of CRO/CMO capabilities, capacity, compliance history, performance, and readiness to support supply.
• Partner with Business Development, Corporate Strategy, Non-clinical, Clinical, Pharmacovigilance, Quality, Regulatory, Finance, Legal, Program Management, and Technical Operations stakeholders.
• Prepare diligence reports, risk registers, executive presentations, and post-transaction recommendations.
• Lead regulatory input into term sheets, agreements, quality agreements, supply agreements, transition plans and governance.
• Establish enterprise regulatory diligence strategy, standards, tools, templates and risk frameworks.
• Advise leadership on regulatory considerations for strategic transactions.

Skills

Regulatory strategy

Due diligence

Leadership

Cross-functional collaboration

Executive communication

GMP knowledge

Education

Master's or PhD in pharmaceutical sciences or related

Equivalent combination of education and experience

Job description

Travere Therapeutics in San Diego is seeking a Vice President, Regulatory Strategy Diligence to lead regulatory due diligence for external business opportunities, assessing risks across clinical, manufacturing, and regulatory readiness.

The role requires 15+ years in pharma/biotech with regulatory and business development focus, strong leadership, and ability to translate complex regulatory findings into executive recommendations. Travel 10–20% domestically and internationally.