Global Regulatory Strategy Manager - Remote (US)

Sarepta Therapeutics; Denver (CO); Hybrid; USD 116,000 - 145,000; Full time

Job summary

Sarepta Therapeutics seeks a Regulatory Affairs professional to lead clinical trial regulatory activities in the United States and globally. You will coordinate submissions, clock in cross-functional teams, and support lifecycle regulatory strategies for multiple programs.

This US-based remote position emphasizes collaboration, compliance, and timely regulatory deliverables. A strong background in IND/CTA submissions and ICH guidelines is essential for success at Sarepta.

Qualifications

• Knowledge of drug development and regulatory process.
• Knowledge of ICH guidelines, IND/ CTA, IMPDs, Orphan drug designation.
• Demonstrated experience preparing submissions with clear content and format requirements.
• Adaptive communication skills across interpersonal, written and verbal.
• Ability to multi-task, prioritize, manage timelines, and organize complex information.
• Experience working in cross-functional project teams.
• Strong accountability, ethics, and attention to detail.
• Proficiency with Microsoft Office Applications (Word, Excel, Outlook).

Responsibilities

• Act as regulatory lead for clinical trial activities and submissions.
• Review regulatory submission materials prepared by CROs.
• Support regulatory strategy for assigned markets and product lifecycles.
• Ensure country-specific submissions are prepared and compliant.
• Provide regulatory guidance to Global Regulatory Leads and project teams.
• Contribute to global regulatory strategy and participate in GRTs.
• Coordinate with RA CRO to monitor trial progression and compliance.
• Escalate issues to RA stakeholders with clear communication.
• Follow Sarepta SOPs and regulatory expectations in documentation.

Skills

Drug development

Regulatory process

ICH guidelines

IND/CTA submissions

Cross-functional teamwork

Project management

Communication skills

Attention to detail

Microsoft Office

Adobe Suite

Education

BS or equivalent in a relevant field

MS in Regulatory Affairs or RAC

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Adobe Suite

Job description

Sarepta Therapeutics seeks a Regulatory Affairs professional to lead clinical trial regulatory activities in the United States and globally. You will coordinate submissions, clock in cross-functional teams, and support lifecycle regulatory strategies for multiple programs.

This US-based remote position emphasizes collaboration, compliance, and timely regulatory deliverables. A strong background in IND/CTA submissions and ICH guidelines is essential for success at Sarepta.