Vice President, Regulatory Strategy Diligence

Education/Experience Requirements

• Master’s or PhD (preferred) 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 with experience with regulatory and pharmaceutical development with a Business Development focus including clinical, manufacturing and technical operations, process, or related functions required; preferred experience with progressing late-stage assets from clinical development through commercialization.
• 8 years of previous people management and leadership experience.
• Experience in similar strategic management position with significant experience interacting with executive leadership required.
• Professional experience in similar role within biotech/pharmaceutical industry, preferably 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 articulate and communicate complex regulatory and technical information into clear risks, recommendations, timelines, and mitigation plans to both internal and external audiences, including senior management.
• Excellent communication and influencing skills; rare disease, orphan drug development, global supply, regulatory submission, or post-deal integration experience preferred.

• Lead the Regulatory due diligence for licensing, acquisition, partnership, and external innovation opportunities by assessing readiness risks for clinical/commercial-stage assets.
• Evaluate drug/device regulatory development including all levels of product development, pediatrics, Regulatory strategies, Agency feedback, risks and mitigations along with Timelines and development strategies.
• Own the integrated regulatory risk assessment and recommendation for each opportunity, Identify and champion activities relating to risk and its mitigation distinguishing transaction critical issues; communicate key assumptions, dependencies, potential timeline effects, and proposed mitigation.
• Evaluate CMC drug substance/product manufacturing, product development, control strategies, analytical, validation, stability, technology transfer, and lifecycle management plans.
• Review regulatory aspects of CRO/CMO capabilities, capacity, compliance history, performance, network redundancy, supply continuity, and readiness to support clinical and/or commercial supply.
• Partner with Business Development, Corporate Strategy, Non-clinical, Clinical, Pharmacovigilance, Quality, Regulatory, Finance, Legal, Program Management, and Technical Operations stakeholders.
• Prepare timely, concise 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 governances.
• Establish enterprise regulatory diligence strategy, standards, tools, templates and risk frameworks.
• Advise leadership on regulatory considerations for strategic transactions.
• Additional duties assigned as needed.