Associate Director, Regulatory Systems

About the role

The Associate Director, Regulatory Business Systems will lead the strategy, governance, implementation, and optimization of Regulatory Affairs technology platforms that support global regulatory operations and submission activities. This individual will serve as the business owner for key regulatory systems and partner closely with Regulatory Affairs, Regulatory Operations, IT, Quality, Clinical, and external vendors to deliver scalable, compliant, and efficient business solutions. The ideal candidate brings deep expertise in regulatory processes, business systems management, and cross-functional collaboration within a biotechnology or pharmaceutical environment. This role will play a critical part in advancing RevMed's regulatory systems roadmap and enabling operational excellence across the regulatory organization.

Responsibilities

• Serve as the business owner and strategic lead for Regulatory Affairs systems, including Veeva RIM, Veeva Registrations, DocuBridge, and related regulatory platforms.
• Drive the long-term strategy, roadmap, and governance model for regulatory business systems aligned with organizational objectives.
• Lead implementation, enhancement, integration, and optimization initiatives across regulatory technology platforms.
• Partner with Regulatory Affairs, Regulatory Operations, Quality, Clinical, Safety, and IT teams to gather business requirements and deliver scalable system solutions.
• Ensure systems are validated, maintained, and operated in compliance with applicable GxP regulations and industry standards, including 21 CFR Part 11, Annex 11, and GAMP5.
• Establish and maintain governance processes for change management, release management, system documentation, training, and lifecycle support.
• Oversee integrations between regulatory systems and adjacent enterprise platforms, including eTMF, Quality, Clinical, and Safety systems.
• Collaborate with vendors and managed service providers to ensure system performance, issue resolution, and continuous improvement.
• Develop and monitor system KPIs, user adoption metrics, and operational effectiveness measures.
• Support internal audits, regulatory inspections, and compliance activities related to regulatory systems and electronic records.
• Provide leadership and guidance on emerging regulatory technologies, digital transformation initiatives, and process harmonization opportunities.
• Mentor team members and contribute to building scalable operational capabilities within Regulatory Operations and Regulatory Systems.
• Required Skills, Experience and Education:
• Bachelor's degree in Life Sciences, Information Systems, Business Administration, or related discipline.
• 8+ years of experience supporting Regulatory Affairs systems, Regulatory Operations, or regulated business systems within the biotechnology or pharmaceutical industry.
• Hands-on experience with regulatory platforms such as Veeva RIM, Veeva Registrations, DocuBridge, or comparable regulatory systems.
• Strong understanding of global regulatory submission processes, eCTD publishing, and regulatory information management.
• Experience supporting GxP-compliant computerized systems validation and compliance activities.
• Demonstrated experience leading cross-functional system implementations, upgrades, and business process improvements.
• Strong knowledge of system governance, SDLC methodologies, and change management practices.
• Excellent communication, analytical, organizational, and stakeholder management skills.
• Preferred Skills:
• Experience supporting global health authority submissions and regulatory operations at a clinical-stage or commercial biotechnology company.
• Familiarity with integrations across Regulatory, Clinical, Quality, Safety, and enterprise content management systems.
• Experience working with cloud-based SaaS platforms and vendor-managed services.
• Knowledge of data governance, reporting, analytics, and business process automation within Regulatory Affairs.
• #LI-Hybrid #LI-YG1
• The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary ran

Benefits

Additional Information

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

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