[Hiring] Vice President, Regulatory Strategy @Lumanity

Role Description

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.

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.

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.