Vice President, Regulatory Strategy

Lumanity

Vice President leading regulatory strategy at Lumanity, focusing on biopharma regulatory expertise and practice growth. Partnering with C-suite executives to drive transformational regulatory strategies across global markets.

Posted 5/9/2026full-timeRemote • 🇺🇸 United StatesLeadWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory strategiespre-IND meetingsType C meetingsEOP2 discussionsaccelerated approval pathwayscomplex regulatory strategiesbiologicscell therapygene therapycombination products

Soft Skills

trusted advisormentorshipcollaborationinfluencingstrategic partnershipleadershipcommunicationteam managementconsulting methodologiesbusiness development

Certifications

PhDMPHMS in life sciencesMS in regulatory affairsMBARAC certification