Global Regulatory Strategy Lead – Remote

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

Benefits offered by this job

Physical and Emotional Wellness

Financial Wellness

Support for Caregivers

Job summary

Sarepta Therapeutics seeks a Regulatory Affairs professional to lead clinical trial activities, coordinate submissions with CROs, and drive regulatory strategies across markets. The role supports product lifecycle activities and requires collaboration with cross-functional teams.

The position is based in the United States with hybrid work options and offers a salary range that reflects market standards for senior regulatory roles.

Qualifications

• BS or equivalent with 5+ years of relevant experience.
• MS in Regulatory Affairs or RAC.
• Knowledge of ICH guidelines, IND/CTA, IMPDs, Orphan drug designation.

Responsibilities

• Acts as the regulatory affairs clinical lead for trial activities and submissions.
• Reviews regulatory submission materials for CRO submissions.
• Implements regulatory activities across product lifecycle for assigned markets.

Skills

Drug development knowledge

ICH guidelines knowledge

Submission preparation experience

Adaptive communication

Multi-tasking & project management

Cross-functional collaboration

Attention to detail & ethics

MS Office proficiency

Education

BS or equivalent in relevant field

MS in Regulatory Affairs or RAC

Tools

Microsoft Word

Excel

Adobe Suite

Job description

Sarepta Therapeutics seeks a Regulatory Affairs professional to lead clinical trial activities, coordinate submissions with CROs, and drive regulatory strategies across markets. The role supports product lifecycle activities and requires collaboration with cross-functional teams.

The position is based in the United States with hybrid work options and offers a salary range that reflects market standards for senior regulatory roles.