Associate Director, Regulatory Systems

Key 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.