Senior Manager, Regulatory Information Systems

Benefits

Additional Information

Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients. What Sarepta Offers At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas: Physical and Emotional Wellness Financial Wellness Support for Caregivers For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us The Importance of the Role Sarepta is searching for an experienced professional to lead and support critical activities related to Sarepta's Regulatory Information Management System (RIMS), which is used to develop regulatory submissions for dispatch to health authorities globally. The Senior Manager, RIM will have responsibility for assuring that RIMS is used in an effective manner across the organization in adherence to applicable internal procedures and guidelines, that users have the knowledge, skills, and training to use RIMS effectively for their needs, and that RIMS is monitored from a data perspective. The Opportunity to Make a Difference 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 May be required to support preparation for inspection readiness 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 as well as authoring, review, and execution of test scripts to support thrice yearly and ad hoc system enhancements Operate under medium to low supervision Receives assignments as objectives from regulatory operations leadership, and establishes operational objectives and determines 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 Erroneous decisions may result in critical operational delays and jeopardize overall business activities More about You 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 princi