Job Details

The Opportunity:  The Director, Regulatory Affairs – Business Excellence & Execution

The Director, Regulatory Affairs – Business Excellence & Execution supports operational coordination and execution across Global Regulatory Affairs (GRA), enabling alignment, communication, and follow-through between the Sr. Vice President of Regulatory Affairs and the broader regulatory organization.

This role partners closely with the Sr. VP and Regulatory Leadership Team (RegLT) to support department priorities, manage leadership team operations, and coordinate activities across regulatory subfunctions.

The position focuses on keeping priorities moving forward by facilitating cross-functional coordination, maintaining visibility into execution, and ensuring consistent follow-through across GRA. This includes supporting governance forums, enabling communication across functions, and providing insight into progress, risks, and key activities.

Primary Responsibilities

Regulatory Leadership & Governance

• Coordinate RegLT meetings and department-wide offsites, including agenda development, content coordination, and action tracking.

• Support follow-through on leadership decisions, ensuring clear ownership and timelines.

• Lead the Regulatory Working Group to support alignment of cross-functional priorities, policies, and procedures.

• Facilitate discussions, support decision-making, and track execution of agreed actions.

Leadership Support & Cross-Functional Coordination

• Support communication and alignment between the Sr. VP of Regulatory Affairs and regulatory subfunctions.

• Provide coordination and follow-through on leadership priorities and initiatives.

• Coordinate cross-functional regulatory activities, including planning, tracking, and issue escalation as needed.

• Liaise across subfunctions to ensure consistent communication and awareness of key activities.

Execution Tracking & Reporting

• Maintain visibility into key regulatory activities, deliverables, and commitments across subfunctions.

• Develop and maintain dashboards and reports to track progress, risks, and execution gaps.

• Provide regular updates to support awareness and decision-making across leadership.

Process & Business Excellence

• Support development and refinement of regulatory processes and ways of working.

• Coordinate cross-functional input into procedural documentation to ensure consistency and alignment.

• Contribute to continuous improvement efforts to enhance efficiency and clarity across GRA.

Required Skills, Experience and Education:

• Minimum of 8-12 years of experience in Regulatory Affairs, with experience in business operations, project management, or functional execution within the life sciences industry.

• Strong understanding of how Regulatory Science and supporting regulatory subfunctions interact.

• Proven ability to manage multiple priorities with strong attention to detail and consistent follow-through.

• Experience working in a cross-functional, matrixed environment.

• Demonstrated ability to coordinate stakeholders and support execution of complex initiatives.

• Strong communication and interpersonal skills, with the ability to engage effectively across all levels, including senior leadership.

• Ability to operate independently, driving work forward with minimal direction in a fast-paced environment.

• Strong organizational skills and judgment, with the ability to navigate ambiguity.

Preferred Skills:

• Experience supporting leadership team operations (e.g., meetings, offsites, action tracking) .

• Experience working closely with or supporting senior leadership.

• Experience facilitating cross-functional forums or structured discussions.

• Experience developing dashboards or reports to track execution and progress.

• Familiarity with regulatory systems (e.g., RIMS) and project management tools (e.g., Smartsheet).

• Experience contributing to process improvement or operational initiatives.