Manager, Global Regulatory Strategy

Sarepta Therapeutics • Cambridge, MA

8h • $116,000 - $145,000 • Hybrid

About The Position

The Manager, Global Regulatory Strategy participates in clinical and nonclinical regulatory strategic discussions and supports clinical trial, registration, and related activities for multiple products. The role is responsible for cross-functional execution of regulatory activities at the team level for assigned programs and markets, supports implementation of regulatory strategy, and provides regulatory support for registration and post-licensing activities. The position also maintains knowledge of assigned market regulatory procedures and builds relationships across Global Regulatory Affairs (GRA) and other stakeholder groups to support effective communication and implementation of regulatory activities.

The role serves as the regulatory affairs clinical lead for clinical trial activities, including planning, preparing, and tracking clinical trial applications (CTAs), responding to agency queries, IP release, CTA questionnaires, and label review. It reviews regulatory agency submission materials prepared by CROs on Sarepta’s behalf, supports product lifecycle activities, ensures country-specific submissions are assembled and prepared, and provides regulatory support to Global Regulatory Leads and Global Regulatory Teams. The position works closely with regulatory CROs to maintain trial progression and compliance, provides clinical-trial regulatory guidance, maintains compliant documentation and records, and develops knowledge of evolving regulations and guidance.

The position works on issues requiring evaluation of varied factors and an understanding of business trends, communicates and escalates issues to supervisors and relevant regulatory stakeholders, follows established processes and operational policies, and works toward objectives with meaningful impact on the unit and organization. The position is hybrid, with onsite work at a Sarepta facility in the United States and/or attendance at company-sponsored in-person events from time to time. Candidates must be authorized to work in the U.S.

Requirements

• BS degree or equivalent.
• 5–8 years of relevant experience.
• Knowledge of drug development and regulatory processes.
• Knowledge of ICH guidelines, IND/CTA, IMPDs, and orphan drug designation.
• Demonstrated experience preparing submissions and a clear understanding of submission content and format requirements.
• Adaptive interpersonal, written, and verbal communication skills.
• Ability to multitask, prioritize, manage projects and timelines, and organize and track complex information.
• Experience working in cross-functional project teams.
• Accountability, sound judgment, high ethical standards, and attention to quality and detail.
• Proficiency with Microsoft Office applications, including Word, Excel, and Outlook, and Adobe Suite systems.
• Authorization to work in the U.S.

Responsibilities

• Act as the regulatory affairs clinical lead for clinical trial activities, including planning, preparation, and tracking of CTAs, agency-query responses, IP release, CTA questionnaires, and label review.
• Review regulatory agency submission materials for submissions conducted by a CRO on behalf of Sarepta.
• Implement regulatory activities supporting product lifecycle activities for assigned markets.
• Ensure effective assembly and preparation of country-specific submissions.
• Support the Global Regulatory Lead in defining and communicating regulatory strategy for assigned markets and products, and provide input to project teams through Global Regulatory Teams.
• Contribute to global regulatory strategy and execution and participate in Global Regulatory Teams.
• Work with regulatory CROs to maintain trial progression and compliance.
• Provide regulatory guidance related to clinical trial activities and communicate updates cross-functionally as needed.
• Ensure documentation management and record keeping comply with regulatory expectations and Sarepta SOPs.
• Develop and maintain knowledge of relevant evolving regulations and guidance.
• Escalate and communicate issues effectively to the supervisor and relevant regulatory stakeholders.
• Follow processes and operational policies when selecting methods and techniques to obtain solutions.

Benefits

• Competitive compensation and benefit package.
• Benefits and work-life resources supporting physical and emotional wellness, financial wellness, and caregivers.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager