Vice President, Regulatory Strategy Diligence

Travere Therapeutics

. Lead Regulatory due diligence for licensing, acquisition, partnership, and external innovation opportunities .

Posted 10/31/2026full-timeSan Diego • California • United StatesLead💰 $285,000 - $385,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in regulatory due diligence, risk assessment, and strategic management within the pharmaceutical and biotechnology sectors. Proficient in leading cross-functional collaborations and synthesizing complex regulatory information into actionable insights.

Highest-signal resume keywords

Regulatory Due DiligencePharmaceutical DevelopmentGMP RequirementsPeople ManagementRisk Mitigation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory StrategyClinical Trial DesignAnalytical DevelopmentTechnology TransferProduct Lifecycle ManagementRisk AssessmentDue DiligenceAsset EvaluationRegulatory SubmissionCommercialization

Soft Skills

Excellent CommunicationCollaborationDecision-MakingAttention to DetailInterpersonal Skills

Tools & Technologies

Diligence ReportsRisk RegistersExecutive PresentationsQuality AgreementsTransition Plans

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryCROCMORare DiseaseOrphan Drug DevelopmentGlobal SupplyPost-Deal IntegrationClinical DevelopmentManufacturing Operations

About the role

Key responsibilities & impact

Lead Regulatory due diligence for licensing, acquisition, partnership, and external innovation opportunities
Assess readiness risks for clinical- and commercial-stage assets
Evaluate drug/device regulatory development, pediatric development, regulatory strategies, agency feedback, risks, mitigations, timelines, and development strategies
Own integrated regulatory risk assessments and recommendations for each opportunity
Identify and champion risk mitigation activities and distinguish transaction-critical issues
Communicate assumptions, dependencies, potential timeline effects, and proposed mitigation
Evaluate CMC drug substance/product manufacturing, product development, control strategies, analytical work, validation, stability, technology transfer, and lifecycle management plans
Review regulatory aspects of CRO/CMO capabilities, capacity, compliance history, performance, network redundancy, supply continuity, and clinical/commercial supply readiness
Partner with Business Development, Corporate Strategy, Non-clinical, Clinical, Pharmacovigilance, Quality, Regulatory, Finance, Legal, Program Management, and Technical Operations stakeholders
Prepare diligence reports, risk registers, executive presentations, and post-transaction recommendations
Lead regulatory, documentation, and technical input into term sheets, definitive agreements, quality agreements, supply agreements, transition plans, and joint collaboration governance
Establish enterprise regulatory diligence strategy, standards, tools, templates, and risk frameworks
Advise leadership on regulatory considerations for strategic transactions
Contribute to post-deal integration planning and continuous improvement of diligence tools and evaluation standards
Perform additional duties as assigned

Requirements

What you’ll need

Master’s or PhD in pharmaceutical sciences, biological sciences, engineering, chemistry, chemical engineering, or related scientific discipline required; equivalent combination of education and applicable job experience may be considered
15+ years of relevant experience in pharmaceutical or biotechnology industries
Experience with regulatory and pharmaceutical development with a Business Development focus, including clinical, manufacturing and technical operations, process, or related functions
Preferred experience progressing late-stage assets from clinical development through commercialization
8 years of previous people management and leadership experience
Experience in a similar strategic management position with significant executive leadership interaction
Professional experience in a similar role within the biotech/pharmaceutical industry
Preferred experience supporting both biologics and small molecule development and commercialization
Strong understanding of GMP requirements, regulatory expectations and guidance, clinical trial design, statistical and process validation, analytical development, technology transfer, and product lifecycle management
Demonstrated experience leading or contributing to due diligence, asset evaluations, licensing, acquisitions, partnerships, or external alliance assessments
Ability to synthesize and communicate complex regulatory and technical information into clear risks, recommendations, timelines, and mitigation plans
Excellent communication and influencing skills
Preferred rare disease, orphan drug development, global supply, regulatory submission, or post-deal integration experience
Skilled at building partnerships across internal functions and with external partners, consultants, CROs, CDMOs, and SMEs
Ability to operate in a fast-paced, confidential, matrixed environment with shifting priorities and compressed timelines
Strong interpersonal, organizational, verbal and written communication skills
Excellent decision-making, collaboration, and attention-to-detail skills
Ability to travel 10–20% domestically and internationally

Benefits

Comp & perks

Premium health, financial, work-life and well-being offerings for eligible employees and dependents
Wellness and employee support programs
Life insurance
Disability insurance
Retirement plans with employer match
Generous paid time off
Short-term incentive
Long-term incentive compensation in company stock
Face-to-face work with colleagues and/or onsite in San Diego
Ability to travel domestically and internationally