Director of Regulatory Affairs, Business Excellence

Director of Regulatory Affairs, Business Excellence1 week ago Be among the first 25 applicantsThis range is provided by Bayside Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range$130.00/hr - $140.00/hrDirector of Regulatory Affairs, Business ExcellenceW2 Contract-to-HireSalary Range: $270,400 - $291,200 per yearLocation: Redwood City, CA - Remote RoleJob SummaryThe 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 ResponsibilitiesAdvance 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 QualificationsMinimum 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 QualificationsExperience with audit/inspection readiness and regulatory documentation systems.Proficiency in MS Office Suite, Smartsheet, or similar project/portfolio tools.Desired Skills and ExperienceRegulatory Affairs, Business Excellence, Strategic Operations, Process Improvement, Compliance Management, SOP Development, Cross-functional Leadership, Project Management, Change Management, Stakeholder Engagement, Resource Planning, Budget Management, Headcount Planning, Meeting Management, Initiative Planning, Regulatory Governance, Work Instructions, RACI Development, Policy Development, Procedure Documentation, Training Coordination, Onboarding Programs, Life Sciences, Pharmaceutical Industry, Medical Device Industry, Regulatory Compliance, FDA Regulations, Global Regulations, Audit Readiness, Inspection Readiness, Documentation Systems, MS Office Suite, Smartsheet, Project Portfolio Management, Strategic Planning, Analytical Skills, Leadership Through Influence, Process Design, Operational Excellence, Performance Excellence, Innovation Management, Collaboration, Team Leadership, Communication Skills, Organizational Skills, Problem-solving, Decision-making, Business Operations, Regulatory Frameworks, Quality Systems, GxP Compliance, Regulatory Strategy, Cross-functional Coordination, Action Item Tracking, Risk Management, Continuous ImprovementBayside 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 levelDirectorEmployment typeContractJob functionProject Management, Research, and ScienceReferrals increase your chances of interviewing at Bayside Solutions by 2xSign in to set job alerts for "Director of Regulatory Affairs" roles.J-18808-Ljbffr