Manager, Global Regulatory Strategy

Sarepta Therapeutics • Cambridge, MA

1d • Hybrid

About The Position

The Manager, Global Regulatory Strategy participates in clinical and nonclinical regulatory strategic discussions and supports clinical trial, registration, and post-licensing activities for multiple products. The role is responsible for cross-functional execution of regulatory activities at the team level for assigned programs and markets, implementing regulatory strategy, and providing regulatory support for medicinal product registration and lifecycle activities. The position maintains knowledge of regulatory procedures in assigned markets and builds relationships across Global Regulatory Affairs and with other stakeholders to support effective communication and efficient execution.

As regulatory affairs clinical lead for clinical trial activities, the role plans, prepares, and tracks clinical trial applications and related activities, responds to agency queries, supports investigational product release, and reviews labels and submission materials. The Manager works with CROs and cross-functional teams to support trial progression, compliance, country-specific submissions, documentation management, and implementation of global regulatory strategy. This is a U.S.-based position described as remote in one section and hybrid in another; the posting states that occasional on-site work at a U.S. facility and/or attendance at company-sponsored in-person events is expected.

The position requires knowledge of drug development and regulatory processes, relevant guidelines, submission requirements, and assigned-market regulations. It involves evaluating complex information, exercising sound judgment, communicating and escalating issues, and working within established processes and operational policies. Sarepta describes its mission as developing precision genetic medicines for rare diseases and offers benefits and work-life resources supporting physical and emotional wellness, financial wellness, and caregivers.

Requirements

• Bachelor of Science degree or equivalent.
• At least 5 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 Word, Excel, Outlook, and Adobe Suite systems.
• Must be authorized to work in the United States.

Nice To Haves

• Master’s degree in Regulatory Affairs.
• Regulatory Affairs Certification (RAC).

Responsibilities

• Act as the regulatory affairs clinical lead for clinical trial activities, including planning, preparation, and tracking of CTAs; responding to agency queries; IP release; CTA questionnaires; and label review.
• Review regulatory agency submission materials prepared by a CRO on behalf of Sarepta.
• Implement regulatory activities supporting product lifecycle activities in 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 closely with the regulatory affairs CRO to maintain trial progression and compliance.
• Provide regulatory guidance related to clinical trial activity and communicate updates cross-functionally.
• Ensure documentation management and record keeping meet regulatory expectations and Sarepta SOPs.
• Develop and maintain knowledge of relevant evolving regulations and guidance.
• Escalate and effectively communicate issues to the supervisor and relevant regulatory affairs stakeholders.
• Maintain knowledge of assigned-market regulatory procedures and build relationships within Global Regulatory Affairs and with other stakeholders.

Benefits

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

What This Job Offers

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