Senior Manager, Regulatory Affairs Device

Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. 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

Contributes to regulatory strategic discussion and implementation of global regulatory strategies for investigational devices/Companion Diagnostics (CDx)/Combination Products to support business objectives. Supports products registrations and acts as the regulatory affairs lead for clinical trial activities for multiple programs. Contributes to the development of high quality documentation (e.g., IDEs, IVDR technical documents, reports, and correspondences) to support global Health Authority interactions. May oversee activities of junior regulatory personnel. Builds/maintains relationships globally and cross-functionally to ensure effective communication & efficient implementation of regulatory activities for assigned programs. Applies and further develops knowledge of assigned market regulatory procedures.

The Opportunity to Make a Difference

• Prepares regulatory submissions and correspondence with regulatory authorities, including IDE, SRD, Q-subs, EU Technical Files, etc.
• Coordinates and manages regulatory activities required for submissions to regulatory agencies for assigned products
• Works with diagnostic partners to mutually align on co-development regulatory needs and determine regulatory paths toward development and global registration activities
• Engage internal and external stakeholders to define and implement process improvements as needed 
• Contributes to developing regulatory strategies for assigned projects while accurately interpreting and reflecting regulatory and Corporate guidelines
• Ensures documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs
• Supports inspection readiness
• Maintains/further develops knowledge of relevant evolving regulation and guidance
• Contributes to global regulatory strategy and execution and participate in Global Regulatory Teams (GRTs)

Impact and Scope

• Works on issues where analysis of situations or data requires a knowledge of organizational objectives and current business trends
• Establishes and assures adherence to budgets, schedules, work plans, and performance requirements
• Works on objectives that have major impact on functional area and the organization
• Erroneous decisions may result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.

More about You

• BS or equivalent with 8+ years relevant experience
• Experience working in GRTs and cross functional teams
• Knowledge of drug development, ICH guidelines and device or drug/device combination product regulatory framework
• Experience working on clinical studies for device, drug or drug/device combination products
• Demonstrated experience with and a clear understanding of submission content and format requirements
• Ability to successfully manage projects/timelines, organize/track complex information & prioritize, by communicating with internal and external stakeholders
• Adaptive communication skills (including interpersonal, written, verbal) and able to influence others without authority
• Solid sense of accountabil