Vice President, Regulatory Strategy

Role Overview

• 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

Requirements

• 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

Benefits

• Competitive salary plus bonus scheme
• Medical, dental, and vision insurance options
• 401(k) plan with employer match
• Flexible PTO
• Flexible spending accounts for health and dependent care
• Health savings account option with employer contribution
• Employee Assistance Program
• Paid short-term and long-term disability coverage and much more