VP, Regulatory Strategy & Diligence — Remote

Travere Therapeutics; Atlanta (GA); Hybrid; USD 285,000 - 385,000; Full time

Benefits offered by this job

Health insurance

Generous paid time off

Stock-based compensation

Job summary

Travere Therapeutics is seeking a Vice President of Regulatory Strategy Diligence to lead the Regulatory Due Diligence team, assessing licensing, acquisition, partnership, and external innovation opportunities. You will evaluate regulatory risks across clinical, manufacturing, CMC, and commercial readiness, collaborating with BD, Legal, QA, and other functions to support strategic decisions.

The ideal candidate brings deep expertise in regulatory strategy for small molecules, biologics, and

Qualifications

• Master's or PhD in pharmaceutical sciences, biological sciences, engineering, chemistry, or related field.
• 15+ years of relevant experience in pharma/biotech with a Business Development focus including clinical, manufacturing and technical operations.
• 8 years of previous people management and leadership experience.
• Experience in interacting with executive leadership in strategic transactions.
• Experience in biotech/pharmaceutical industry with biologics and small molecule development.
• Strong understanding of GMP requirements and regulatory expectations.

Responsibilities

• Lead regulatory due diligence for licensing, acquisition, partnership, and external innovation opportunities.
• Evaluate drug/device regulatory development including pediatrics, strategies, agency feedback, risks and mitigations.
• Own integrated regulatory risk assessment and recommendation for each opportunity.
• Evaluate CMC drug substance/product manufacturing, control strategies, validation, and lifecycle plans.
• Review CRO/CMO capabilities, capacity, and readiness to support supply.
• Partner with Business Development, Clinical, QA, Regulatory, Finance, Legal, and Operations.
• Prepare diligence reports, risk registers, executive presentations, and post-transaction recommendations.
• Lead regulatory input into term sheets, agreements, and governance.

Skills

Regulatory strategy

Due diligence

Cross-functional leadership

Executive communication

Clinical development

GMP/regulatory compliance

Education

Master's or PhD in pharmaceutical sciences or related field

PhD preferred

Job description

Travere Therapeutics is seeking a Vice President of Regulatory Strategy Diligence to lead the Regulatory Due Diligence team, assessing licensing, acquisition, partnership, and external innovation opportunities. You will evaluate regulatory risks across clinical, manufacturing, CMC, and commercial readiness, collaborating with BD, Legal, QA, and other functions to support strategic decisions.

The ideal candidate brings deep expertise in regulatory strategy for small molecules, biologics, and