VP, Regulatory Strategy & Due Diligence

Travere Therapeutics

United States

On-site

USD 285,000 - 385,000

Full time

14 hours ago
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Benefits offered by this job

Premium health benefits
Retirement plan with employer match
Generous paid time off

Job summary

Travere Therapeutics is seeking a Vice President, Regulatory Strategy Diligence to lead the Regulatory Due Diligence team. You will assess clinical/commercial assets for licensing, acquisitions, partnerships, and external innovation, identifying risks and practical mitigations across development paths and manufacturing readiness.

The ideal candidate brings deep regulatory development expertise across small molecules, biologics, ATMPs, and companion diagnostics, with experience in confidential

Qualifications

  • Master’s or PhD preferred in pharmaceutical-related field.
  • 15+ years of relevant experience in pharma/biotech with regulatory and BD focus.
  • 8+ years of leadership experience.
  • Experience interacting with executive leadership in biotech/pharma.
  • Strong ability to translate complex regulatory/technical info into clear risks and recommendations.

Responsibilities

  • Lead regulatory due diligence for licensing, acquisition, partnership, and external opportunities.
  • Evaluate regulatory development across product lifecycle, including pediatrics and CMC.
  • Own integrated regulatory risk assessment and communicate assumptions, dependencies and mitigations.
  • Review CMC drug substance/product manufacturing, analytical development, and lifecycle plans.
  • Assess CRO/CMO capabilities and readiness to support clinical and commercial supply.
  • Collaborate with BD, Clinical, Regulatory, Quality, Legal and Operations teams.

Skills

Regulatory strategy
Due diligence
Leadership
Cross-functional collaboration
Regulatory submission
GMP knowledge

Education

Master’s or PhD in pharmaceutical sciences or related field
15+ years in pharma/biotech with regulatory and BD focus
8 years of people management experience

Job description

Travere Therapeutics is seeking a Vice President, Regulatory Strategy Diligence to lead the Regulatory Due Diligence team. You will assess clinical/commercial assets for licensing, acquisitions, partnerships, and external innovation, identifying risks and practical mitigations across development paths and manufacturing readiness.

The ideal candidate brings deep regulatory development expertise across small molecules, biologics, ATMPs, and companion diagnostics, with experience in confidential

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