Vice President, Regulatory Strategy

This is a fully remote position, open to applicants in United States.

📋 Description

• Serves as a trusted strategic partner to C-suite executives and other heads in the pharmaceutical and biotech sectors, influencing regulatory strategies that span various development programs and corporate initiatives.

• Offers expert regulatory guidance on intricate, multi-indication development programs, including innovative modalities such as cell/gene therapy, biologics, and advanced therapeutics.

• Collaborates with other Lumanity practices to provide integrated solutions that tackle interconnected regulatory, clinical, and quality challenges.

• Works alongside the SVP & Practice Lead to interpret changes in the regulatory landscape (AI/digital submissions, global harmonization, policy evolution) into avenues for practice growth and competitive advantage.

• Develops regulatory perspectives that shape industry standards, influence regulatory policy discussions, and position Lumanity as a leading authority in regulatory strategy consulting.

• Advances consulting methodologies and creates new service offerings to meet emerging regulatory challenges and client demands.

• Actively supports the Clinical & Regulatory P&L in partnership with the SVP and Practice Lead, achieving annual revenue goals while ensuring targeted profitability margins.

• Drives individual and team business development performance, spearheading pursuit strategies for complex, high-value regulatory engagements while fostering business development capabilities throughout the practice.

• Establishes and upholds delivery quality standards across the regulatory team, ensuring consistency in regulatory strategy outputs while balancing profitability against client value.

• Shapes the regulatory talent strategy through succession planning, mentorship of senior regulatory leaders, and the development of next-generation regulatory competencies.

• Promotes collaboration and knowledge sharing across markets, enhancing the reuse of regulatory frameworks and best practices.

• Represents Lumanity at senior industry forums and regulatory conferences, establishing external credibility and enhancing market presence.

• Tracks the regulatory competitive landscape and translates insights into practice positioning and service evolution.

⛳️ Requirements

• A minimum of 20+ years of progressive regulatory experience with a proven track record in both consulting settings and in-house biopharma regulatory leadership roles.

• Direct experience in leading regulatory strategies for development programs across all stages and various therapeutic areas and product types.

• Demonstrated success in managing regulatory practices or teams.

• Established ability to act as a trusted advisor to VP-level and C-suite executives in the pharmaceutical/biotech sectors.

• Extensive knowledge across pre-IND to post-market regulatory activities, including designations, accelerated approval pathways, and complex regulatory strategies.

• Significant experience leading Pre-IND meetings, Type C meetings, EOP2 discussions, and other essential regulatory interactions.

• International regulatory experience in major markets (EMA, Health Canada, PMDA) with a strong understanding of global regulatory harmonization.

• Deep regulatory expertise in at least two major therapeutic areas (oncology, CNS, rare disease, immunology, etc.).

• Experience with various product types, including small molecules, biologics, cell/gene therapies, and combination products.

• PhD, MPH, or MS in life sciences, regulatory affairs, or a related field.

• MBA, RAC certification, or equivalent business/regulatory qualifications.

• Proven history of achieving annual revenue targets alongside demonstrated budget management experience.

• A successful track record in opening new markets or service lines within regulatory consulting.

• Published thought leadership in regulatory matters, along with speaking engagements and recognition as an authority in the regulatory industry.

🏝️ Benefits

• Competitive salary along with a bonus scheme.

• Options for medical, dental, and vision insurance.

• 401(k) plan with employer matching.

• Flexible paid time off.

• Flexible spending accounts for health and dependent care.

• Health savings account option with employer contributions.

• Employee Assistance Program.

• Paid short-term and long-term disability coverage, among other benefits.