Associate Director, Regulatory Information Management Systems

The Associate Director, RIM will lead operational, administrative, and strategic support for Sarepta’s Regulatory Information Management System (RIMS), used to develop regulatory submissions for dispatch to health authorities globally.

Responsibilities:
- Lead and manage administrative/operational support of assigned systems
- Partner with Regulatory Affairs and cross-functional stakeholders to gather and translate business requirements into system solutions
- Monitor, assess, and improve support processes (user access, UX, procedural documents, training, issue resolution)
- Lead improvements to business processes and system configurations
- Ensure compliant documentation management and record keeping (regulatory expectations and SOPs)
- Establish/maintain system governance (change control, release management, documentation)
- Define/monitor key risk and performance metrics for assigned systems
- Support inspection readiness by ensuring correspondence and submissions are complete, traceable, and retrievable
- Provide customized RIMS training; assist with training material development
- Determine/track KPIs for utilization, stability, and data quality
- Master RIMS reports/dashboards
- Integrate AI and emerging technologies to create efficiencies
- Lead RIMS validation (author/review/execute test scripts for enhancements)
- Operate under low supervision

Qualifications:
- BA/BS or equivalent
- 10+ years in document management, regulatory submissions, RIM, archiving, and metrics analysis
- Hands-on Veeva Vault RIM experience (document management, metadata, records lifecycle)
- Expert proficiency with Veeva RIM (Registrations, Submissions, Submissions Archive)
- Strong understanding of regulatory business processes related to RIMS
- Experience with validated computer system change controls and Computer Software Assurance principles
- Knowledge of evolving global regulatory guidance (eCTD, document management, RIM)
- Proficiency: Microsoft Office (Word, Excel, Outlook) and Adobe
- Strong communication, stakeholder influence, project/timeline management, and problem-solving

Application:
- This is a hybrid role; work on-site in the U.S. and attend in-person events as needed. Candidates must be authorized to work in the U.S.