Global Regulatory Strategy Lead (Remote)

Sarepta Therapeutics; Chicago (IL); Hybrid; USD 116.000 - 145.000; Vollzeit

Zusammenfassung

Sarepta Therapeutics in the United States is seeking a Regulatory Affairs Clinical Lead to oversee regulatory activities for multiple programs. The role involves planning, preparing and tracking CTAs, responding to agency questions, IP release, label reviews, and coordinating with CROs to ensure timely submissions.

This US-based remote/hybrid position requires strong knowledge of ICH guidelines, IND/CTA, and cross-functional collaboration.

Qualifikationen

• BS or equivalent with 5+ years of relevant experience.
• MS in Regulatory Affairs or RAC.
• Knowledge of drug development and regulatory process.

Aufgaben

• Acts as the regulatory affairs clinical lead for clinical trial activities (planning, preparation and tracking of CTAs, response to agency queries, IP release, CTA Qs, label review).
• Reviews regulatory submission materials for CRO submissions on Sarepta's behalf.
• Implements regulatory activities in support of product lifecycle in assigned markets.

Kenntnisse

Drug development

Regulatory knowledge

Submission preparation

Cross-functional

Communication skills

Project management

MS Office

Ausbildung

Bachelor's degree

MS in Regulatory Affairs (RAC)

Tools

Microsoft Office

Adobe Suite

Jobbeschreibung

Sarepta Therapeutics in the United States is seeking a Regulatory Affairs Clinical Lead to oversee regulatory activities for multiple programs. The role involves planning, preparing and tracking CTAs, responding to agency questions, IP release, label reviews, and coordinating with CROs to ensure timely submissions.

This US-based remote/hybrid position requires strong knowledge of ICH guidelines, IND/CTA, and cross-functional collaboration.