Executive Director, Regulatory Strategy, Cell & Gene Therapy

About the role

The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and tactical regulatory knowledge and advanced drug development expertise in Type 1 Diabetes (T1D). The incumbent will be responsible for overseeing the development and implementation of innovative global regulatory strategies for product development and commercialization of programs within the T1D portfolio. This position will manage a group of global/regional regulatory professionals with program leadership responsibilities. This role will play a major role in shaping cohesive regulatory strategy across the programs and ensuring effective integration of broad regulatory ideas/tactics supporting franchise strategy.

Responsibilities

• Leads the development of regulatory strategy for multiple projects in development (from FIH to post‑marketing application stage) within the T1D portfolio, representing regulatory on senior cross‑functional teams and providing strategic input, innovative solutions, and guidance for complex or critical topics.
• Ensures the global regulatory strategy for programs within the portfolio aligns with corporate business objectives and is negotiated with relevant health authorities as appropriate.
• Works with global regulatory program leads and regional representatives to secure unified regulatory input into cross‑functional development teams, clinical programs, and commercial strategy.
• Contributes to the review, authorship, and quality of regulatory submission documents and Health Authority communications.
• Counsels and advises senior management on the status of global Regulatory Affairs strategies, tactics, procedures, and practices.
• Creates and assesses project plans and timelines, assigns and manages staff effectively to prioritize projects and meet key goals on schedule.
• Plays a key role in developing career growth opportunities for staff.
• Influences the regulatory environment through active participation in conferences, industry/agency regulatory meetings, committees, and trade associations.
• Sponsors continuous improvement efforts on existing department processes and strategies, providing recommendations to shape outcomes and resource planning.
• As a people manager, may have financial accountabilities and human‑resource responsibilities for assigned staff.

Requirements

• Demonstrated technical and tactical expertise in regulatory affairs science, including knowledge of regulatory frameworks and external environments.
• Expert knowledge of global/regional/local regulatory legislation, laws, procedures, and guidance for pharmaceutical development of medicines for human use.
• Demonstrated expertise in research and development, preclinical and clinical requirements related to drug development, registration, and maintenance of human pharmaceuticals.
• Expert proficiency in analyzing and interpreting data, protocols, safety reporting, labeling, and other activities across drug‑development phases for assigned products.
• Demonstrated advanced expertise in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, and in leading productive health‑authority interactions.
• Demonstrated advanced expertise in analyzing the adequacy of proposed regulatory pathways and strategies, guiding development teams with recommendations for changes/refinements based on ongoing regulatory outcomes.
• Ability to navigate ambiguity, demonstrate agility, and communicate a strong understanding of requirements, opportunities, risks, and alternatives for developing and maintaining products in the assigned portfolio.
• Builds and sustains strategic partnerships across the organization, especially with cross‑functional leadership for the assigned portfolio.
• Proactively stays current on scientific and clinical advances, competitive intelligence, and changes in the regulatory environment impacting product development.
• Ability to articulate the organization’s strategic vision and core values, and to lead and contribute to improving internal regulatory policies, programs, and initiatives.
• A strong leader who demonstrates sensitivity and understanding of cultural considerations, embraces diversity, and continuously develops staff through feedback, coaching, guidance, and mentoring.
• Enterprise‑minded, capable of strategic thinking, and proposes innovative solutions to regulatory problems.
• Demonstrates excellent communication skills, able to impact and influence decisions at