Remote Global Regulatory Strategy Lead

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

Zusammenfassung

Sarepta Therapeutics is seeking a Regulatory Affairs Clinical Lead to guide regulatory strategy and submissions for assigned markets. You will work cross-functionally to support clinical trial activities, post-licensing activities, and communication with regulatory authorities.

This US-based remote/hybrid role requires 5+ years in regulatory affairs, knowledge of ICH guidelines, IND/CTA, and experience preparing submissions.

Qualifikationen

• Knowledge of drug development and regulatory processes.
• Familiarity with ICH guidelines, IND/CTA, and Orphan designation.
• Experience preparing submissions with clear content and format.
• Strong communication skills and cross-functional collaboration.

Aufgaben

• Act as regulatory lead for clinical trial activities.
• Review regulatory submissions and coordinate CRO inputs.
• Support global regulatory strategy and cross-functional teams.
• Ensure compliance with regulatory expectations and Sarepta SOPs.
• Develop knowledge of evolving regulations.

Kenntnisse

Drug development

ICH guidelines

IND/CTA

Orphan designation

Submission planning

Ausbildung

BS or equivalent

MS in Regulatory Affairs

Jobbeschreibung

Sarepta Therapeutics is seeking a Regulatory Affairs Clinical Lead to guide regulatory strategy and submissions for assigned markets. You will work cross-functionally to support clinical trial activities, post-licensing activities, and communication with regulatory authorities.

This US-based remote/hybrid role requires 5+ years in regulatory affairs, knowledge of ICH guidelines, IND/CTA, and experience preparing submissions.