Vice President, Regulatory Strategy

Lumanity is dedicated to improving health outcomes by accelerating and optimizing access to life-changing medicines. As a global strategic partner that brings together strategy, evidence, engagement, and technology, we were designed to engineer breakthrough value to tackle our clients’ toughest challenges by revolutionizing how value is generated, demonstrated, and communicated.

The Vice President, Regulatory Strategy is a senior enterprise leader who combines deep regulatory technical expertise with proven consulting and biopharma experience to drive practice growth and deliver transformational regulatory strategies for VP and C-suite client executives. This role partners with the SVP & Practice Lead to shape the future direction of Lumanity's Clinical & Regulatory practice while maintaining direct accountability for revenue growth, client relationships, and team development across global markets.

The VP serves as a senior regulatory authority, translating regulatory landscape evolution into practice opportunities, building unique competitive capabilities, and positioning the firm as the go-to regulatory strategy authority for complex, high-stakes pharmaceutical development programs.

• Acts as trusted strategic partner to pharmaceutical and biotech C-suite executives and other functional heads, influencing enterprise-wide regulatory strategies that extend across multiple development programs and corporate initiatives
• Provides authoritative regulatory guidance on complex, multi-indication development programs, including novel modalities (cell/gene therapy, biologics, advanced therapeutics)
• Partners with other Lumanity practices to deliver integrated solutions addressing interconnected regulatory, clinical, and quality challenges

• Partners with SVP & Practice Lead to translate regulatory landscape changes (AI/digital submissions, global harmonization, policy evolution) into practice growth opportunities and competitive differentiation
• Develops regulatory points of view that influence industry standards, shapes regulatory policy dialogue, and positions Lumanity as the authoritative voice in regulatory strategy consulting
• Evolves consulting methodologies and develops new service offerings to address emerging regulatory challenges and client needs

• Proactively supports the Clinical & Regulatory P&L, in collaboration with the SVP and Practice Lead, achieving annual revenue targets while maintaining target profitability margins
• Dives personal and team BD performance, leading pursuit strategies for complex, high-value regulatory engagements while mentoring BD capability across the practice

• Sets and reinforces delivery quality standards across regulatory team, ensuring consistency in regulatory strategy outputs while balancing profitability with client value
• Shapes regulatory talent strategy through succession planning, mentorship of senior regulatory leaders, and development of next-generation regulatory capabilities
• Champions collaboration and knowledge sharing across markets, accelerating reuse of regulatory frameworks and best practices

• Represents Lumanity at senior industry forums and regulatory conferences building external credibility and market presence
• Monitors regulatory competitive landscape and translates insights into practice positioning and service evolution

• Minimum 20+ years progressive regulatory experience with demonstrated success in both consulting environments and in-house biopharma regulatory leadership roles
• Direct experience leading regulatory strategies for development programs throughout all stages and across different therapeutic areas and product types
• Demonstrated success managing regulatory practices or teams
• Proven ability to serve as trusted advisor to pharmaceutical/biotech VP-level and C-suite executives
• Deep expertise across pre-IND through post-market regulatory activities, including designations, accelerated approval pathways, and complex regulatory strategies
• Extensive experience leading Pre-IND meetings, Type C meetings, EOP2 discussions, and other critical regulatory interactions
• International regulatory experience across major markets (EMA, Health Canada, PMDA) with understanding of global regulatory harmonization
• Deep regulatory expertise in 2+ major therapeutic areas (oncology, CNS, rare disease, immunology, etc.)
• Experience across multiple product types including small molecules, biologics, cell/gene therapies, and combination products
• PhD, MPH, or MS in life sciences, regulatory affairs, or related field
• MBA, RAC certification, or equivalent business/regulatory qualifications
• Proven track record achieving annual revenue targets with demonstrated budget management experience
• Success in opening new markets or service lines within regulatory consulting
• Published regulatory thought leadership, speaking engagements, and recognition as regulatory industry authority

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