Global Regulatory Strategy Lead (Remote)

Sarepta Therapeutics; California; Hybrid; USD 116.000 - 145.000; Vollzeit

Benefits dieser Stelle

Wellness program

Financial wellness

Caregiver support

Zusammenfassung

Sarepta Therapeutics is seeking an experienced Regulatory Affairs professional to lead regulatory activities for clinical trials and product lifecycle across assigned markets. The role focuses on planning, submission reviews, and cross-functional collaboration to ensure compliant, timely outcomes.

The position is US-based and regulatory-focused, requiring knowledge of ICH guidelines and strong communication.

Qualifikationen

• Knowledge of drug development and regulatory process.
• Knowledge of ICH guidelines, IND/CTA, IMPDs, Orphan drug designation.
• Demonstrated experience preparing submissions, with clear understanding of submission content and format requirements.
• Adaptive communication skills (interpersonal, written, verbal).

Aufgaben

• Acts as the regulatory clinical lead for trial activities (planning, preparation, tracking of CTAs, agency responses).
• Reviews regulatory submission materials prepared by CROs on Sarepta's behalf.
• Implements regulatory activities in support of product lifecycle in assigned markets.
• Ensures country-specific submissions are properly assembled and prepared.
• Provides regulatory input to Global Regulatory Lead and project teams via GRT for assigned products/markets.
• Contributes to global regulatory strategy and execution and participates in Global Regulatory Teams.
• Coordinates with RA CRO to maintain trial progression and compliance.
• Offers regulatory guidance across cross-functional teams as needed.
• Ensures documentation management and record keeping meet Sarepta SOPs.
• Develops knowledge of evolving regulation and guidance.
• Escalates and communicates issues to supervisor and relevant RA stakeholders.
• Follows defined processes and policies to obtain regulatory solutions.
• Works on objectives with meaningful impact on the unit and organization.
• Recognizes impact of decisions on GRA deliverables.

Kenntnisse

Regulatory knowledge

Submission experience

ICH guidelines

Adaptive communication

Multitasking & prioritization

Cross-functional teamwork

Accountability & ethics

Microsoft Office proficiency

Ausbildung

BS or equivalent

MS in Regulatory Affairs or RAC

Tools

Microsoft Office

Jobbeschreibung

Sarepta Therapeutics is seeking an experienced Regulatory Affairs professional to lead regulatory activities for clinical trials and product lifecycle across assigned markets. The role focuses on planning, submission reviews, and cross-functional collaboration to ensure compliant, timely outcomes.

The position is US-based and regulatory-focused, requiring knowledge of ICH guidelines and strong communication.