Senior Director- Counsel, Infectious Disease & Vaccines, Regulatory Legal

Responsibilities

• Vaccine regulatory strategy: Serve as the primary regulatory legal partner to the Vaccines & Infectious Disease team, providing day-to-day and strategic legal counsel on vaccine-specific regulatory pathways globally.
• Health authority engagement: Lead regulatory legal strategy for agency interactions with global health authorities, including high-profile regulatory issues, inspections, enforcement matters, dispute resolution, and other significant agency engagements.
• Advisory committee and immunization policy: Advise on advisory committee strategy and immunization policy dynamics (e.g., ACIP), in partnership with Policy and Government Affairs.
• Emerging regulatory issues: Maintain strong situational awareness of evolving laws, regulations, and guidance applicable to vaccines and biologics to anticipate and assess risks and opportunities.
• Enterprise leadership: Partner with senior leaders across Clinical Development, Regulatory Affairs, Manufacturing & Quality, Patient Safety, Commercial, Policy, and Legal to shape regulatory strategies for the vaccines and infectious disease portfolio.

Requirements

• Portfolio integration: Lead regulatory legal workstreams for the integration of newly acquired assets and platforms; providing tailored, program-specific counsel across all stages of product and platform lifecycle.
• Legal capability building: Build and scale the regulatory legal capability for the portfolio, including governance models and external counsel strategy. Partner across Legal to align support and prepare for portfolio growth.
• Portfolio lifecycle execution: Serve as the lead for the implementation and execution of regulatory legal support across the portfolio lifecycle including clinical development, pharmacovigilance, and manufacturing/quality in collaboration with RLT and other legal subject-matter experts.
• Cross-functional partnership: Deliver integrated legal guidance to key functions (Clinical Development, Regulatory Affairs, Patient Safety, Manufacturing & Quality, Commercial, and Policy) while operating as a proactive solutions-oriented partner in a complex, matrixed environment.