Remote Global Regulatory Strategy Manager

Sarepta Therapeutics; Rhode Island; Remote; USD 116,000 - 145,000; Full time

Job summary

Sarepta Therapeutics is seeking a Regulatory Affairs professional to lead clinical trial regulatory activities and prepare submissions across assigned markets. You will coordinate with cross-functional teams, CRO partners, and internal stakeholders to ensure timely, compliant deliverables.

The role emphasizes strategic regulatory planning, ongoing guidance through trial lifecycles, and robust documentation practices in a US-based remote environment.

Qualifications

• 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 multi-task, prioritize, manage projects/timelines, and organize/track complex information.
• Experience working in cross functional project teams.
• Strong sense of accountability, ethics, and attention to detail.
• Proficient with Microsoft Office Applications.

Responsibilities

• Act 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 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 and preparation of country-specific submissions.
• Provides regulatory support to Global Regulatory Lead in defining and communicating regulatory strategy for assigned markets.
• 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 related 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 evolving regulation and guidance.
• Works on issues where analysis of situations requires evaluation of multiple factors.
• Escalates and communicates issues to supervisor and RA stakeholders.
• Follows processes and policies in selecting methods for solutions.
• Works on objectives with meaningful impact on unit and organization.
• Erroneous decisions or failure to execute has medium impact to GRA deliverables.

Skills

Regulatory knowledge

ICH guidelines

Submission experience

Cross-functional teamwork

Communication skills

Project management

Quality and ethics

MS Office

Education

BS or equivalent with 5+ years

MS in Regulatory Affairs or RAC

Tools

MS Office (Word, Excel, Outlook)

Job description

Sarepta Therapeutics is seeking a Regulatory Affairs professional to lead clinical trial regulatory activities and prepare submissions across assigned markets. You will coordinate with cross-functional teams, CRO partners, and internal stakeholders to ensure timely, compliant deliverables.

The role emphasizes strategic regulatory planning, ongoing guidance through trial lifecycles, and robust documentation practices in a US-based remote environment.