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
Participates in clinical and nonclinical regulatory strategic discussions, supports multiple products’ clinical trial and registration and activities. Responsible for cross-functional execution of regulatory activities at the team level to support assigned programs and markets. Supports the implementation of regulatory strategy for assigned markets & provides regulatory support for the registration/post-licensing activities of medicinal products. Maintains and develops knowledge of assigned market regulatory procedures. Builds/maintains relationships within GRA & other stakeholders to support effective communication & efficient implementation of regulatory activities for assigned markets & activities.The Opportunity to Make a Difference
- Acts as the regulatory affairs clinical lead for clinical trial activities, including but not limited to planning, preparation and tracking of CTAs, response to agency queries, IP release, CTA Questionnaires, label review, etc.
- Reviews of all regulatory agency submission materials for submissions conducted by a CRO on behalf of Sarepta
- Implements regulatory activities in support of product lifecycle activities for assigned markets
- Ensures effective assembly & preparation of country specific submissions
- Provides regulatory support to Global Regulatory Lead in definition & communication of regulatory strategy for assigned markets for assigned products & inputs into project teams via GRT, in support of GRA goals
- Contributes to global regulatory strategy and execution and participates in Global Regulatory Teams
- Works closely with RA CRO to maintain trial progression and compliance
- Provides regulatory guidance, in relation to clinical trial activity, and updates cross- functionally as needed
- Ensures documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs
- Develops and maintains knowledge of relevant evolving regulation and guidance
- Works on issues where analysis of situations or data requires evaluation of a variety of factors and an understanding of current business trends
- Escalates and effectively communicates issues to supervisor and other relevant RA stakeholders
- Follows processes and operational policies in selecting methods and techniques for obtaining solutions
- Works on objectives that have meaningful impact on unit and the organization
- Erroneous decisions or failure to execute has medium impact to overall GRA deliverables
More about You
Skills and Competencies
- Knowledge of drug development and regulatory process
- Knowledge of ICH guidelines, IND/ CTA, IMPDs, Orphan drug designation
- Demonstrated experience preparing submissions, with and a clear understanding of submission content and format requirements
- Adaptive communication skills (including interpersonal, written, verbal)
- Ability to successfully multi-task, prioritize, manage projects/timelines, and organize/track complex information
- Experience working in cross functional project teams
- Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and details
- Proficiency with Microsoft Office Applications; Word, Excel, Outlook, and Adobe Suite systems
Education and Experience
- BS or equivalent with 5-8 years of relevant experience
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.