Director of Regulatory Affairs, Business Excellence

W2 Contract-to-Hire

Salary Range: $270,400 - $291,200 per year

Location: Redwood City, CA - Remote Role

Job Summary:

The Director of Regulatory Affairs – Business Excellence role provides strategic operational support to the Head of Regulatory Affairs and their leadership team by strengthening execution, improving processes, and ensuring compliance across department activities. Focused on operational execution aspects of the Regulatory Affairs department, the role helps ensure regulatory processes and governance are effective, compliant, and aligned with expectations. The ideal candidate is a collaborative problem-solver who brings structure to complex work and drives meaningful change through process design, project oversight, and leadership engagement.

Duties and Responsibilities:

• Advance the priorities of the Head of Regulatory Affairs and the Regulatory Leadership Team (RegLT) by supporting business and department operations, initiative planning, and execution. Provide input on ongoing projects, resource utilization, and operational alignment across the department, while helping refine regulatory processes, standards, and capabilities to meet global and cross-functional objectives.
• Manage RegLT meetings and department initiatives, including planning, agenda development, logistics, scheduling, and tracking of action items through completion.
• Lead the Regulatory Working Group, composed of RegLT direct reports, to align cross-functional policies, procedures, and priorities. Provide regulatory guidance, drive decision-making, and ensure timely execution of action items in coordination with the RegLT.
• Manage and consolidate input for resource decision support, including headcount, budget, and resource utilization tracking.
• Represent Regulatory Affairs in cross-functional efforts to develop, review, and maintain regulatory processes and procedural documents (e.g., work instructions, RACIs). Coordinate with stakeholders and subject matter experts to ensure sufficient input and buy-in on regulatory policies and procedures, while maintaining consistency and compliance with corporate policies and global regulations.
• Develop, write, maintain, and revise department-level SOPs and other regulatory procedural documents in compliance with company-wide policies and regulatory requirements.
• Coordinate the development and rollout of training for changes to regulatory processes and ways of working, including the onboarding program.
• Build and maintain strong internal and external networks through a regulatory lens to gather insights, share best practices, and support regulatory-focused initiatives that drive business excellence.
• Inspire and promote a culture of innovation, collaboration, and performance excellence across Regulatory Affairs.

Requirements and Qualifications:

• Minimum of 7–10 years of experience in Regulatory Affairs, emphasis in business operations, or project/process management in the life sciences industry.
• Strong understanding of regulatory processes and compliance frameworks; experience with SOP development and maintenance preferred.
• Proven project and change management capabilities, including planning, execution, and stakeholder communication.
• Demonstrated ability to lead through influence, drive alignment, and manage competing priorities.
• Excellent interpersonal, organizational, and communication skills.
• Strong strategic thinking and analytical mindset with attention to detail. 

Preferred Qualifications:

• Experience with audit/inspection readiness and regulatory documentation systems.
• Proficiency in MS Office Suite, Smartsheet, or similar project/portfolio tools.

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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