Hybrid Associate Director, Regulatory Affairs

at MSD

• Job title: Associate Director, Regulatory Affairs
• Job type: Full Time
• Experience level: Senior, Lead
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Tech skills: Vault
• Location requirements: Hybrid, San Jose, United States

About the role

• Lead digital and physical regulatory records management for a global health care leader. Overseeing archival operations and ensuring compliance within Regulatory Affairs & Clinical Safety.

Responsibilities

• Support the BSO for the Veeva Vault RIM Submissions Archive, providing support to system development, maintenance, enhancements, and monitoring.
• Liaise with IT, Learning & Development, and global stakeholders to define and implement user requirements, workflows, and metadata standards.
• Ensure compliance with global regulatory standards and internal SOPs for electronic submissions and correspondence.
• Collaborate with publishing, registration, and planning teams to maintain alignment across the regulatory lifecycle.
• Oversee the central archive team, including offshore contractors and temporary onshore staff.
• Manage archival activities related to acquisitions, divestitures, audits, litigation, and regulatory inquiries.
• Ensure accuracy, throughput, and quality of archival work, including budget oversight for temporary staffing.
• Coordinate with Business Development Execution teams and system owners of related platforms (e.g., eTMF) for migration and record alignment.
• Support GRACS’ long-term strategy to unify regulatory platforms under Veeva RIM, ensuring cross-functional coordination and system interoperability.
• Represent the archive function in strategic planning meetings, system integration workshops, and change management initiatives.
• Advocate for continuous improvement in archival processes, leveraging analytics and stakeholder feedback.

Requirements

• Bachelor’s degree in a business, scientific, or operational discipline relevant to the life sciences and/or operations areas or a minimum of 12+ years of industry experience, at least 6 of those in a regulatory/compliance industry utilizing records/document management systems.
• Direct experience in Veeva RIM Submissions Archive.
• Proven leadership in managing both digital systems and physical archives.
• Strong understanding of regulatory submission types (eCTD, IND, NDA, ANDA) and Health Authority requirements.
• Knowledge of system development lifecycle, data/content administration concepts, and capabilities applying technology within a business environment.
• Experience supporting and working with tools and systems used in a regulatory/compliance environment, including managing archival collection or distribution for acquisitions, divestitures, litigations, audits, regulatory inquiries, and ad hoc work.
• Deep knowledge of managing records related to submissions content, health authority correspondences, and other regulatory documents.
• Demonstrated capabilities managing and mentoring staff, including managing onshore and offshore vendors for records management and related activities.
• Proven leadership in Change Management with an ability to lead and influence others outside of a direct reporting relationship.
• Demonstrated collaborative skills and ability to work in cross-functional and international environments.
• Excellent communication, stakeholder engagement, and project management skills.
• Advanced English skills.

Benefits

• Flexible Work Arrangements