Senior Manager, Regulatory Operations

Sarepta Therapeutics•Cambridge, MA

1d•$136,000 - $170,000•Hybrid

About The Position

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 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 able 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 What Now? We’re always looking for solution-oriented, critical thinkers. So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply. #LI-Hybrid #LI-ES1 This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time. The targeted salary range for this position is $136,000 - $170,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. Candidates must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify. Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. 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. Our deep pipeline is driven by our multi-platform technologies in siRNA, RNA and gene therapy. For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.

Requirements

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 able 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

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
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