Remote Global Regulatory Strategy Manager

Sarepta Therapeutics; North Carolina; Hybrid; USD 116,000 - 145,000; Full time

Benefits offered by this job

Physical and Emotional Wellness

Financial Wellness

Support for Caregivers

Job summary

Sarepta Therapeutics is seeking a Regulatory Affairs professional to lead clinical trial activities, manage regulatory submissions, and coordinate cross-functional teams across assigned markets. You will partner with CROs and internal stakeholders to maintain trial progression and ensure compliant submissions.

The role emphasizes regulatory strategy, quality documentation, and knowledge of evolving guidelines, supporting Sarepta's portfolio of therapies in rare diseases.

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 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.

Responsibilities

• 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.
• 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.
• 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.

Skills

Drug development

ICH guidelines

Submission content

Cross-functional teams

Multi-tasking

Communication

Accountability

Ethical standards

Education

BS or equivalent

MS in Regulatory Affairs or RAC

Tools

Microsoft Office

Adobe Suite

Job description

Sarepta Therapeutics is seeking a Regulatory Affairs professional to lead clinical trial activities, manage regulatory submissions, and coordinate cross-functional teams across assigned markets. You will partner with CROs and internal stakeholders to maintain trial progression and ensure compliant submissions.

The role emphasizes regulatory strategy, quality documentation, and knowledge of evolving guidelines, supporting Sarepta's portfolio of therapies in rare diseases.