VP, Regulatory Strategy & Diligence

Travere Therapeutics; Oklahoma City (OK); On-site; USD 285,000 - 385,000; Full time

Job summary

Travere Therapeutics seeks a Vice President, Regulatory Strategy Diligence to lead regulatory due diligence for external opportunities, collaborating with Business Development and senior leaders. You will assess regulatory pathways, risk, and timing for clinical and commercial assets, including CMC, manufacturing, and analytics, to support strategic transactions.

The role requires extensive experience in pharma/biotech regulatory affairs, leadership, and a track record of advising executives on

Qualifications

• 15+ years in pharmaceutical/biotech with regulatory and BD focus including clinical, manufacturing and technical operations
• 8 years of people management experience
• Experience interacting with executive leadership
• Biologics and small molecule development experience preferred
• Strong understanding of GMP requirements and regulatory expectations

Responsibilities

• Lead regulatory due diligence for licensing, acquisition, partnership and external innovation opportunities
• Assess readiness risks for clinical/commercial-stage assets across development paths
• Own integrated regulatory risk assessment and recommendations, communicating assumptions and mitigations
• Evaluate CMC drug substance/product manufacturing and lifecycle plans
• Review CRO/CMO capabilities and readiness to support supply
• Collaborate with cross-functional stakeholders including BD, Clinical, Quality, Regulatory, Legal
• Prepare diligence reports, risk registers, and executive presentations
• Contribute to term sheets, agreements, and governance documents
• Establish enterprise regulatory diligence standards and risk frameworks
• Advise leadership on regulatory considerations for strategic transactions
• Travel up to 10-20% domestically and internationally

Skills

Regulatory strategy

Due diligence

Biologics

GMP

Executive communication

Leadership

Education

Master's or PhD in pharmaceutical sciences/related

Job description

Travere Therapeutics seeks a Vice President, Regulatory Strategy Diligence to lead regulatory due diligence for external opportunities, collaborating with Business Development and senior leaders. You will assess regulatory pathways, risk, and timing for clinical and commercial assets, including CMC, manufacturing, and analytics, to support strategic transactions.

The role requires extensive experience in pharma/biotech regulatory affairs, leadership, and a track record of advising executives on