Remote Global Regulatory Strategy Lead

Sarepta Therapeutics; United States; Híbrido; USD 110.000 - 160.000; Jornada completa

Descripción de la vacante

Sarepta Therapeutics seeks a Regulatory Affairs professional to act as the clinical lead for regulatory activities across trials and submissions. You will coordinate with CROs, maintain adherence to ICH guidelines, and support regulatory strategy for multiple markets.

The role requires strong cross-functional collaboration, rigorous attention to detail, and the ability to manage multiple projects simultaneously in a US-based hybrid environment.

Formación

• BS or equivalent with 5+ years of relevant experience.
• MS in Regulatory Affairs or RAC.
• Experience preparing submissions and knowledge of submission formats.

Responsabilidades

• Act as regulatory affairs lead for clinical trial activities and CTAs.
• Review regulatory submissions and ensure alignment with CRO activities.
• Support regulatory strategy for assigned markets and product lifecycles.
• Coordinate with GRA and stakeholders for timely submissions.
• Maintain documentation and ensure regulatory compliance across markets.

Conocimientos

Drug development knowledge

ICH guidelines

Regulatory submissions

Communication skills

Time management

Cross-functional teams

Attention to detail

Office software

Educación

BS or equivalent with 5+ years

MS in Regulatory Affairs or RAC

Herramientas

Microsoft Office

Adobe Suite

Descripción del empleo

Sarepta Therapeutics seeks a Regulatory Affairs professional to act as the clinical lead for regulatory activities across trials and submissions. You will coordinate with CROs, maintain adherence to ICH guidelines, and support regulatory strategy for multiple markets.

The role requires strong cross-functional collaboration, rigorous attention to detail, and the ability to manage multiple projects simultaneously in a US-based hybrid environment.