Vice President, Regulatory Strategy

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

📋 Description

• Serve as a reliable strategic partner to C-suite executives and functional leaders in the pharmaceutical and biotech sectors.

• Shape regulatory strategies that span the enterprise, influencing various development programs and corporate initiatives.

• Offer expert regulatory guidance on intricate, multi-indication development programs, including innovative modalities.

• Collaborate with other Lumanity teams to provide cohesive regulatory, clinical, and quality solutions.

• Convert changes in the regulatory landscape into opportunities for practice growth and competitive advantage.

• Create regulatory perspectives that impact industry standards and contribute to policy discussions.

• Innovate consulting methodologies and introduce new service offerings.

• Support the Clinical & Regulatory Profit and Loss (P&L) and meet annual revenue objectives while ensuring profitability margins are upheld.

• Spearhead strategies for pursuing complex, high-value regulatory projects and enhance business development capabilities through mentoring.

• Establish quality standards for delivery within the regulatory team.

• Influence the regulatory talent strategy through succession planning and mentorship initiatives.

• Foster collaboration and knowledge sharing across different markets.

• Represent Lumanity at prominent industry forums and regulatory conferences.

• Track the regulatory competitive landscape and convert insights into practice positioning and service development.

⛳️ Requirements

• At least 20 years of progressively responsible regulatory experience with proven success in consulting environments and in-house biopharma regulatory leadership roles.

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

• Proven success in managing regulatory practices or teams effectively.

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

• Extensive expertise in pre-IND through post-market regulatory activities, including designations, accelerated approval pathways, and complex regulatory strategies.

• Significant experience in leading Pre-IND meetings, Type C meetings, End of Phase 2 discussions, and other essential regulatory communications.

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

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

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

• Advanced degree (PhD, MPH, or MS) in life sciences, regulatory affairs, or a related field.

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

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

• Experience launching new markets or service lines within regulatory consulting.

• Published thought leadership in regulatory affairs, 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 featuring employer matching.

• Flexible paid time off (PTO).

• Flexible spending accounts for health and dependent care.

• Health savings account option with employer contributions.

• Employee Assistance Program available.

• Paid short-term and long-term disability coverage.