Responsibilities / Position overviewThe 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.
Essential Duties/Responsibilities:Strategic Leadership & Client Partnership- 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
Practice Strategy & Innovation- 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
Commercial Accountability & Growth- 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
Delivery Excellence & Team Leadership- 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
Market Presence & External Influence- 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
Qualifications- 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
BenefitsWe offer our employees a comprehensive benefits package that focuses on what matters to you - health and well-being, personal finances, professional development, and a healthy work/life balance:
- 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
-#LI-remote
