VP, Regulatory Diligence & Strategic Transactions

Regulatory Jobs; San Diego (CA); Presencial; USD 285.000 - 385.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Total rewards

Benefits package

Descripción de la vacante

Travere Therapeutics is seeking a Vice President, Regulatory Strategy Diligence to lead the Regulatory Due Diligence team and assess regulatory risks for external business development opportunities. The role requires coordinating with multiple functions to support transaction decisions and post-deal integration.

The ideal candidate brings deep regulatory experience across small molecules, biologics and ATMPs, with strong strategic and communication skills for executive audiences.

Formación

• Master’s or PhD in pharmaceutical sciences, biology, chemistry or related field.
• 15+ years of regulatory/pharma/biotech experience with BD focus including clinical, manufacturing and operations.
• 8+ years of leadership/people management experience.
• Experience interacting with executive leadership in a strategic role.
• Strong understanding of GMP, regulatory expectations, clinical trials, analytical development and tech transfer.

Responsabilidades

• Lead regulatory due diligence for licensing, acquisition, partnership and external opportunities.
• Evaluate regulatory development across product lifecycles including pediatrics and agency feedback.
• Own integrated regulatory risk assessment and recommendations for each opportunity.
• Review CMC, manufacturing, development, control strategies and lifecycle plans.
• Assess CRO/CMO capabilities, capacity and readiness to support supply.
• Collaborate with BD, Clinical, Regulatory, Legal, QA and other stakeholders.
• Prepare diligence reports, risk registers and executive presentations.
• Contribute to term sheets, quality agreements and transition plans.
• Establish enterprise regulatory diligence standards and risk frameworks.
• Advise leadership on regulatory considerations for strategic transactions.

Conocimientos

Regulatory due diligence

Regulatory strategy

Executive communication

Cross-functional collaboration

Risk assessment

Educación

Master’s or PhD in pharmaceutical sciences/related

15+ years pharma/biotech regulatory experience

8+ years people management

Descripción del empleo

Travere Therapeutics is seeking a Vice President, Regulatory Strategy Diligence to lead the Regulatory Due Diligence team and assess regulatory risks for external business development opportunities. The role requires coordinating with multiple functions to support transaction decisions and post-deal integration.

The ideal candidate brings deep regulatory experience across small molecules, biologics and ATMPs, with strong strategic and communication skills for executive audiences.