Global Regulatory Strategy Lead — Remote

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

Job summary

Sarepta Therapeutics, based in the United States, seeks a Regulatory Affairs professional to lead clinical trial regulatory activities, plan CTAs, respond to agency queries, and ensure submissions are compliant with regulatory requirements.

You will support global regulatory strategy, coordinate with CROs, and maintain knowledge of evolving guidelines while working in a hybrid, US-based capacity. Competitive compensation is offered.

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 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 & preparation of country specific submissions
• Provides regulatory support to Global Regulatory Lead in definition & communication of regulatory strategy for assigned markets for assigned products & inputs into project teams via GRT, in support of GRA goals
• 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
• Works on issues where analysis of situations or data requires evaluation of a variety of factors and an understanding of current business trends
• Escalates and effectively communicates issues to supervisor and other relevant RA stakeholders
• Follows processes and operational policies in selecting methods and techniques for obtaining solutions
• Works on objectives that have meaningful impact on unit and the organization
• Erroneous decisions or failure to execute has medium impact to overall GRA deliverables

Education

BS or equivalent with 5+ years of relevant experience

MS in Regulatory Affairs or RAC

Job description

Sarepta Therapeutics, based in the United States, seeks a Regulatory Affairs professional to lead clinical trial regulatory activities, plan CTAs, respond to agency queries, and ensure submissions are compliant with regulatory requirements.

You will support global regulatory strategy, coordinate with CROs, and maintain knowledge of evolving guidelines while working in a hybrid, US-based capacity. Competitive compensation is offered.