Global Regulatory Strategy Lead

Centessa Pharmaceuticals; Boston (MA); On-site; USD 225,000 - 275,000; Full time

Job summary

Centessa Pharmaceuticals in Boston, MA, seeks a Senior Director, Global Regulatory Strategy to lead global regulatory programs from early development through registration and lifecycle management. You will guide NDA planning, submissions, and ensure regulatory alignment across regions while partnering with cross-functional teams.

The role requires extensive experience with global regulatory leadership, interactions with the FDA and other authorities, and the ability to mentor regulatory staff in

Qualifications

• Bachelor's degree in a scientific discipline with 12+ years of progressive regulatory affairs experience, including 5+ years in global regulatory leadership.
• Advanced degree (PhD, PharmD, MS, or JD) preferred with experience supporting small molecule development.
• Significant NDA leadership experience with strategy, submission, and regulatory review responsibilities.

Responsibilities

• Serve as Global Regulatory Lead for assigned development programs from early development through registration and lifecycle management.
• Develop and execute global regulatory strategies across regions and health authorities.
• Lead planning, preparation, and submission of major regulatory filings including INDs, NDAs, and briefing documents.

Skills

Global Regulatory Leadership

FDA/EMA Interactions

Cross-functional Leadership

Regulatory Strategy

Communication & Influence

Education

Advanced degree (PhD/PharmD/MS/JD) preferred

Job description

Centessa Pharmaceuticals in Boston, MA, seeks a Senior Director, Global Regulatory Strategy to lead global regulatory programs from early development through registration and lifecycle management. You will guide NDA planning, submissions, and ensure regulatory alignment across regions while partnering with cross-functional teams.

The role requires extensive experience with global regulatory leadership, interactions with the FDA and other authorities, and the ability to mentor regulatory staff in