Manager, Global Regulatory Strategy

SAREPTA

. Participate in clinical and nonclinical regulatory strategic discussions .

Posted 10/26/2026full-timeUnited StatesMid-LevelSenior💰 $116,000 - $145,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs with a strong focus on clinical trial activities, regulatory submissions, and compliance with evolving regulations. Proficient in managing cross-functional projects and maintaining high standards of documentation and quality.

Highest-signal resume keywords

Regulatory Submissions PreparationKnowledge Of ICH GuidelinesClinical Trial Activities ManagementDrug Development Process KnowledgeCross-Functional Project Team Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsClinical Trial ManagementRegulatory Strategy DevelopmentSubmission Content UnderstandingRegulatory ComplianceProject ManagementDocumentation MaintenanceRegulatory GuidanceDrug Development KnowledgeIND/CTA Knowledge

Soft Skills

Adaptive Communication SkillsMultitasking AbilityOrganizational SkillsAccountabilitySound Judgment

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft OutlookAdobe Suite

Industry Keywords

Regulatory AffairsClinical TrialsPost-Licensing ActivitiesOrphan Drug DesignationCRO CollaborationSOP ComplianceGlobal Regulatory Strategy

About the role

Key responsibilities & impact

Participate in clinical and nonclinical regulatory strategic discussions
Support multiple products’ clinical trial, registration, and post-licensing activities
Execute regulatory activities at the team level for assigned programs and markets
Act as 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 CROs
Implement regulatory activities supporting product lifecycle activities
Assemble and prepare country-specific submissions
Support the Global Regulatory Lead in defining and communicating regulatory strategy
Contribute to global regulatory strategy and execution and participate in Global Regulatory Teams
Work with regulatory-affairs CROs to maintain trial progression and compliance
Provide regulatory guidance on clinical-trial activity and cross-functional updates
Maintain compliant documentation and records according to regulatory expectations and Sarepta SOPs
Develop and maintain knowledge of evolving regulations and guidance
Escalate and communicate issues to supervisors and relevant regulatory-affairs stakeholders

Requirements

What you’ll need

BS or equivalent with 5+ years of relevant experience
Knowledge of drug development and regulatory process
Knowledge of ICH guidelines, IND/CTA, IMPDs, and orphan drug designation
Demonstrated experience preparing regulatory submissions and understanding submission content and format requirements
Adaptive interpersonal, written, and verbal communication skills
Ability to multitask, prioritize, manage projects and timelines, and organize/track complex information
Experience working in cross-functional project teams
Accountability, sound judgment, high ethical standards, and focus on quality and detail
Proficiency with Microsoft Word, Excel, Outlook, and Adobe Suite
Candidates must be authorized to work in the U.S.

Benefits

Comp & perks

Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
Competitive compensation and benefit package
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