Vice President, Regulatory Strategy

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 ADDRESSED BY 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.
• 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 INDUCING THROUGH POST-MARKET REGULATORY ACTIVITIES, INCLUDING DESIGNATIONS, ACCCELERATED 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.).
• EXPERTISE ACROSS MULTIPLE PRODUCT TYPES INCLUDING SMALL MOLECULES, BIOLIGICS, 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.