Director, Business Excellence & Execution in Regulatory Science (RS)

Director, Business Excellence & Execution in Regulatory Science (RS)

W2 Contract

Pay Rate: $100 - $130 per hour

Location: Redwood City, CA - Remote Role

Job Summary:

The Director, Business Excellence & Execution in Regulatory Science (RS) is a strategic and operational partner responsible for driving execution, alignment, and communication across the regulatory science organization, in alignment with Global Regulatory Affairs Business Excellence standards and governance. The ideal candidate brings regulatory expertise alongside strong operational leadership, project management skills, a quality and process-oriented mindset, and the ability to influence within a highly matrixed environment. This role provides operational leadership across RS, ensuring priorities are translated into clear, actionable plans and effectively communicated and executed. The Director will support department priorities and the Regulatory Science Leadership Team (RSLT), manage leadership operations, and enable effective cross-functional communication. Key responsibilities include leading initiatives to enhance efficiency, optimize processes, and embed quality and consistency into ways of working. The role will facilitate key forums, align stakeholders across the function, provide visibility into execution, risks, and progress, driving measurable improvements across RS.

Duties and Responsibilities:

• Manage RSLT meetings and department-wide offsites, including agenda development, content coordination, logistics, and tracking of action items through completion.
• Support tracking and follow-through on leadership team decisions and action items, including clear ownership and timelines.
• Facilitate communication and alignment across RSLT members as well as cross-functionally.
• Represent RS on the cross-functional Regulatory Affairs Working Group, composed of Regulatory Affairs direct reports, to align cross-functional policies, procedures, and priorities.
• Facilitate alignment of regulatory priorities, support decision-making, and ensure timely follow-through on actions in coordination with the RSLT.
• Ensure alignment between Working Group outputs and RSLT priorities, enabling effective escalation and decision-making.
• Enable effective communication and alignment between the Head of Regulatory Science and the broader RS organization.
• Drive the advancement of key priorities and initiatives across RS, ensuring alignment with departmental and corporate objectives.
• Provide operational support to the Head of Regulatory Science, including decision-making support, and follow-through on key actions.
• Track progress against key initiatives and provide visibility to leadership on status, risks, and mitigation plans.
• Provide project management for cross-functional regulatory initiatives, ensuring clear plans, timelines, and accountability.
• Liaise across RS subfunctions to ensure consistent communication and alignment.
• Develop and maintain visibility into key regulatory activities, deliverables, and commitments across RS and to RegLT.
• Generate dashboards and reports to provide leadership with clear insights into progress, risks, resource needs, and execution gaps.
• Enable data-informed decision-making by delivering accurate, timely, and actionable insights .
• Support development, refinement, and implementation of regulatory processes, standards, and ways of working across RS.
• Coordinate and provide cross-functional input into SOPs, work instructions, and procedural documentation to ensure consistency and alignment.
• Drive continuous improvement initiatives to enhance efficiency, clarity, and execution across the function.

Requirements and Qualifications:

• Minimum of 8 years in the pharmaceutical/biotech industry work experience and a minimum of 6 years in Regulatory Sciences, including regulatory strategy and leadership roles.
• Strong leadership, project management, and influencing skills.
• Excellent analytical and problem-solving capabilities.
• Strong communication and stakeholder management skills.
• Experience with data visualization tools (e.g., PowerPoint, Smart Sheet).

Preferred Qualifications:

• Measurable improvements in efficiency, processes, or cycle times.
• Adoption of standardized processes across the organization.
• Improved RSLT performance outcomes.
• Successful tracking and delivery of initiatives.
• Strategic and results-oriented thinker.

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

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.