Associate Director, Regulatory Information Management Systems

Why Sarepta? Why Now? Sarepta is a leader in Duchenne muscular dystrophy and is expanding its portfolio across muscle, central nervous system, and cardiac diseases. The company has launched multiple therapies, including the first ever gene therapy for Duchenne, and continues to develop advanced siRNA, RNA, and gene therapy platforms. What Sarepta Offers Sarepta offers comprehensive benefits that support physical, emotional, and financial wellness, as well as caregiver support. For a full list of benefits, visit the company website. The Importance of the Role The Senior Manager, Regulatory Information Management (RIM) leads and supports critical activities related to Sarepta’s Regulatory Information Management System (RIMS). The role ensures that RIMS is used effectively across the organization, that users are trained and that data is monitored and maintained in compliance with regulatory expectations and internal procedures. Responsibilities Engage with stakeholders to define and improve internal processes as needed to support RIMS and play a major role in determining process changes. Ensure regulatory information management in RIMS is compliant with regulatory expectations and Sarepta procedures. Formulate recommendations for improvements to existing business processes and system configurations. Ensure users provide required metadata to object records and documents in RIMS to facilitate downstream processes and tracking. Provide submission management support and lead end-to-end publishing and submission support. Manage submission timelines, resource planning, and cross‑functional teams to meet submission goals. Maintain accurate archives of regulatory submissions and health authority correspondence to ensure inspection readiness. Ensure data are available in a complete, accurate, and timely manner through use of data monitoring in RIMS from planning of regulatory activities through health authority interaction. Ensure documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs. Perform data monitoring activities to collect and review metadata and conduct updates in collaboration with relevant stakeholders. Support preparation for inspection readiness as required. Define, implement, maintain, and interpret key performance indicators and metrics to evaluate and ensure that regulatory business processes are adhered to in RIMS. Provide focused and customized RIMS training to users; assist with the development of training materials. Master RIMS reports and dashboards to support functions with their reporting and metrics needs. Integrate AI and emerging technologies to create efficiencies. Assist with RIMS validation activities, including identification of users’ needs and authoring, review, and execution of test scripts to support thrice‑yearly and ad‑hoc system enhancements. Operate under medium to low supervision. Receive assignments as objectives from regulatory operations leadership, establish operational objectives, and determine how to use resources to meet timelines and goals. Make decisions for the team regarding process and role responsibilities and work with regulatory operations leadership to ensure continuity of processes throughout the organization. Qualifications BA or BS degree or equivalent. 8 or more years of relevant experience with demonstrated expertise in document management, regulatory submissions, Regulatory Information Management, archiving, and metrics generation and analysis. Deep knowledge of eCTD publishing, submission software, and global regulatory guidelines. Expert proficiency with the Veeva RIM suite of applications, including Registrations, Submissions, and Submissions Archive. Strong understanding of regulatory business processes as they relate to RIMS. Ability to evaluate and recommend process improvements and suggest/implement best practices. Experience with change controls related to validated computer systems and understanding of Computer Software Assurance principles. Fully developed knowledge of relevant evolving regulations and guidance around global operations initiatives impacting Regulatory Operations and the systems they support including eCTD, document management, and RIM. Experience attending industry conferences to keep abreast of best practices and industry trends. Proficiency with Microsoft Office applications, including Word, Excel, Outlook, and Adobe. Adaptive communication skills (including interpersonal, written, and verbal) and ability to influence others without authority. Regularly presents to department, function, and cross‑functionally to train or inform on business processes and relevant information. Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and details. Ability to successfully manage projects/timelines, organize/track complex information and prioritize, and communicate effectively with internal and external stakeholders. Attention to detail and ability to solve problems. Proactive aptitude. Additional Information This is a hybrid position. Employees will be expected to work on site at one of Sarepta’s U.S. facilities and may attend company‑sponsored in‑person events from time to time. The targeted salary range for this position is $136,000–$170,000 per year. Candidates must be authorized to work in the U.S. Equal Opportunity Statement Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e‑Verify. #J-18808-Ljbffr Sarepta Therapeutics