VP, Regulatory Diligence & Strategy

Travere Therapeutics; Boston (MA); Híbrido; USD 285.000 - 385.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Premium health benefits

Financial and work-life programs

Life insurance

Retirement plans with employer match

Generous paid time off

Descripción de la vacante

Travere Therapeutics is seeking a Vice President, Regulatory Strategy Diligence to lead regulatory due diligence for external opportunities. You will evaluate licensing, acquisitions, partnerships, and external innovation, identifying regulatory risks and mitigation strategies across assets, with collaboration across clinical, non-clinical, regulatory, and business development functions.

The ideal candidate has deep regulatory development expertise across small molecules, biologics, ATMPs, and

Formación

• 15+ years in pharma/biotech with regulatory and business development focus
• Experience with late-stage assets from clinical development to commercialization
• Leadership experience managing teams and interacting with senior leadership

Responsabilidades

• Lead regulatory due diligence for licensing, acquisition, partnerships, and external innovation opportunities
• Assess regulatory development for all levels of product development including pediatrics and agency interactions
• Own integrated regulatory risk assessment and communicate key assumptions and mitigations
• Review CMC, manufacturing, and lifecycle management plans for assets
• Evaluate CRO/CMO capabilities and readiness to support clinical and commercial supply
• Collaborate with BD, Clinical, Non-clinical, Pharmacovigilance, Quality, Legal, and Program Management
• Prepare diligence reports, risk registers, and post-transaction recommendations
• Contribute to term sheets, agreements, and governance related to regulatory diligence
• Establish enterprise regulatory diligence standards and risk frameworks
• Advise leadership on regulatory considerations for strategic transactions
• Travel 10-20% domestically and internationally in this role

Conocimientos

Regulatory strategy

Due diligence leadership

Stakeholder management

Executive communication

Team leadership

Educación

Master's or PhD in pharmaceutical sciences or related

Equivalent education/experience in pharma

Descripción del empleo

Travere Therapeutics is seeking a Vice President, Regulatory Strategy Diligence to lead regulatory due diligence for external opportunities. You will evaluate licensing, acquisitions, partnerships, and external innovation, identifying regulatory risks and mitigation strategies across assets, with collaboration across clinical, non-clinical, regulatory, and business development functions.

The ideal candidate has deep regulatory development expertise across small molecules, biologics, ATMPs, and