Director, Regulatory Affairs Business Excellence and Execution

W2 Contract

Pay Rate: $140- $170 per hour

Location: Redwood City, CA - Remote Role

Job Summary:

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.

Duties and Responsibilities:

• 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.
• 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.
• 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.
• Support the 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.

Requirements and Qualifications:

• 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 Qualifications:

• 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.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate. 

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