Global Regulatory Lead — Drive Global Approvals & Strategy

Sarepta Therapeutics; Cambridge (MA); Hybrid; USD 161,000 - 201,000; Full time

Job summary

Sarepta Therapeutics is seeking a Global Regulatory Lead to drive high quality regulatory documents (INDs, CTAs, NDAs) and lead interactions with Health Authorities for global programs. The role partners with cross-functional teams, manages junior staff, and oversees budgets.

Hybrid work on-site at Sarepta facilities in the United States is expected, with periodic international meetings. You will craft regulatory strategies, ensure compliance, and guide teams through FDA engagements, while

Qualifications

• Regulatory leadership experience in major markets.
• Experience preparing regulatory submissions and briefing packages.
• Ability to lead cross-functional teams and manage budgets.

Responsibilities

• Develop regulatory strategies across clinical, nonclinical, and CMC.
• Lead preparation of regulatory submissions (INDs, CTAs, NDAs) and agency meetings.
• Coordinate with global teams and manage regulatory project timelines.

Skills

Regulatory leadership

FDA regulations

Regulatory strategy

Cross-functional leadership

Education

BS or equivalent

Job description

Sarepta Therapeutics is seeking a Global Regulatory Lead to drive high quality regulatory documents (INDs, CTAs, NDAs) and lead interactions with Health Authorities for global programs. The role partners with cross-functional teams, manages junior staff, and oversees budgets.

Hybrid work on-site at Sarepta facilities in the United States is expected, with periodic international meetings. You will craft regulatory strategies, ensure compliance, and guide teams through FDA engagements, while