Manager, Global Regulatory Strategy
Sarepta Therapeutics
Summary
Participates in clinical and nonclinical regulatory strategic discussions, supports multiple products' clinical trial and registration 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 and 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 and other stakeholders to support effective communication and efficient implementation of regulatory activities.
Job description
The Importance of the Role
Participates in clinical and nonclinical regulatory strategic discussions, supports multiple products' clinical trial and registration 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 and 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 and other stakeholders to support effective communication and efficient implementation of regulatory activities.
The Opportunity to Make a Difference
- Acts as the regulatory affairs clinical lead for clinical trial activities, including planning, preparation and tracking of CTAs, response to agency queries, IP release, CTA Questionnaires, label review, etc.
- Reviews 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 and preparation of country specific submissions
- Provides regulatory support to Global Regulatory Lead in definition and communication of regulatory strategy for assigned markets and inputs into project teams via GRT
- 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
- Escalates and effectively communicates issues to supervisor and other relevant RA stakeholders
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 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
Requirements
- BS or equivalent with 5-8 years of relevant experience
- Knowledge of drug development and regulatory process
- Knowledge of ICH guidelines, IND/CTA, IMPDs, Orphan drug designation
- Demonstrated experience preparing submissions with understanding of submission content and format requirements
- Adaptive communication skills (interpersonal, written, verbal)
- Ability to 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
Benefits
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Company overview
Sarepta Therapeutics is a global biotechnology company headquartered in Cambridge, Massachusetts, focused on developing precision genetic medicines for rare diseases. Founded in 1980, the company has evolved into a commercial-stage biopharmaceutical leader with a specialized focus on RNA-based therapeutics and gene therapies. Sarepta's primary mission centers on treating devastating rare genetic disorders, particularly Duchenne muscular dystrophy (DMD), a progressive muscle-wasting disease affecting children. The company has developed multiple FDA-approved treatments including Exondys 51, Amondys 45, Vyondys 53, and the groundbreaking gene therapy ELEVIDYS. Sarepta employs approximately 1,300-1,400 professionals and maintains research facilities across multiple locations. The company's scientific platform leverages Morpholino oligomer technology for exon-skipping therapies and advanced adeno-associated virus (AAV) vectors for gene therapy delivery. With a market capitalization exceeding $2 billion, Sarepta continues to expand its pipeline to address additional rare diseases while building the world's largest gene therapy manufacturing capacity to accelerate patient access to transformative treatments.