Global Regulatory Strategy Lead (Remote)

Sarepta Therapeutics; Massachusetts; Hybrid; USD 116,000 - 145,000; Full time

Benefits offered by this job

Health benefits

Job summary

Sarepta Therapeutics is seeking a Regulatory Affairs professional to lead regulatory activities for clinical trials and submissions. This role involves coordinating with CROs, global regulatory teams, and cross-functional partners to implement regulatory strategies across assigned markets in a US-based remote/hybrid setting.

The candidate will ensure compliance with evolving regulations, manage documentation, and support lifecycle activities for Sarepta's programs, with a focus on quality and

Qualifications

• BS or equivalent with 5+ years of relevant experience.
• MS in Regulatory Affairs or RAC.

Responsibilities

• Act as regulatory affairs clinical lead for trial activities including CTAs, agency queries, and label review.
• Review regulatory submission materials prepared by CROs for Sarepta.
• Implement regulatory activities in support of product lifecycle in assigned markets.
• Provide regulatory guidance and support to global regulatory teams and cross-functional partners.
• Maintain knowledge of evolving regulation and regulatory procedures.
• Ensure documentation management and compliance with Sarepta SOPs.

Skills

Drug development

Regulatory process

ICH guidelines

Submission prep

Cross-functional

Attention to detail

MS Office

Education

BS or equivalent

MS in Regulatory Affairs

Job description

Sarepta Therapeutics is seeking a Regulatory Affairs professional to lead regulatory activities for clinical trials and submissions. This role involves coordinating with CROs, global regulatory teams, and cross-functional partners to implement regulatory strategies across assigned markets in a US-based remote/hybrid setting.

The candidate will ensure compliance with evolving regulations, manage documentation, and support lifecycle activities for Sarepta's programs, with a focus on quality and