Remote Global Regulatory Strategy Lead

Sarepta Therapeutics; Newark (NJ); Hybride; USD 116 000 - 145 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Competitive compensation package

Résumé du poste

Sarepta Therapeutics is seeking a Regulatory Affairs Lead to guide clinical trial activities, review CRO submissions, and support regulatory strategy across markets. This US-based remote role requires collaboration with cross-functional teams and a strong emphasis on timely, compliant submissions.

The position emphasizes adherence to ICH guidelines, robust regulatory know-how, and the ability to communicate effectively with internal teams and external agencies.

Qualifications

• Knowledge of drug development and regulatory processes.
• Experience preparing submissions with understanding of content and format requirements.
• Adaptive communication skills across interpersonal, written, and verbal channels.
• Ability to multi-task, manage projects, and track complex information.

Responsabilités

• Lead regulatory activities for trial progression and submission planning.
• Review regulatory submission materials prepared by CROs for Sarepta.
• Support regulatory strategy implementation for assigned markets and products.
• Prepare country-specific submissions and maintain regulatory documentation.
• Provide guidance and updates to cross-functional teams on regulatory requirements.

Connaissances

Regulatory affairs knowledge

ICH guidelines familiarity

Submission preparation

Cross-functional collaboration

Project management

Communication skills

Attention to detail

Multi-tasking

Formation

BS or equivalent in life sciences

MS in Regulatory Affairs or RAC

Outils

Microsoft Office

Adobe Suite

Description du poste

Sarepta Therapeutics is seeking a Regulatory Affairs Lead to guide clinical trial activities, review CRO submissions, and support regulatory strategy across markets. This US-based remote role requires collaboration with cross-functional teams and a strong emphasis on timely, compliant submissions.

The position emphasizes adherence to ICH guidelines, robust regulatory know-how, and the ability to communicate effectively with internal teams and external agencies.