Associate Director, Regulatory Project Management (Fully Remote)

Centessa Pharmaceuticals; United States; À distance; USD 120 000 - 180 000; Plein temps

Résumé du poste

Centessa Pharmaceuticals is seeking a Regulatory Program Lead to develop and maintain integrated project plans for global regulatory submissions, ensuring adherence to scope, timelines, budgets, and quality standards.

You will act as the primary regulatory timeline liaison across Clinical, Nonclinical, CMC, Quality, and Commercial functions, coordinating cross-functional teams and mitigating risks while preparing for agency meetings.

Qualifications

• Responsibilities include developing and maintaining integrated project plans for global regulatory submissions.
• Act as primary regulatory timeline contact across Clinical, Nonclinical, CMC, Quality, and Commercial functions.
• Identify and mitigate project risks, prepare teams for agency meetings, and lead responses to regulatory queries from global health authorities.

Responsabilités

• Develop and maintain integrated project plans for global regulatory submissions.
• Act as primary regulatory timeline contact across Clinical, Nonclinical, CMC, Quality, and Commercial functions.
• Identify and mitigate project risks, prepare teams for agency meetings, and lead responses to regulatory queries from global health authorities.

Description du poste

• Develop and maintain integrated project plans for global regulatory submissions, ensuring adherence to scope, timelines, budgets, and quality standards.
• Act as the primary regulatory timeline contact across Clinical, Nonclinical, CMC, Quality, and Commercial functions, fostering collaboration and alignment.
• Identify and mitigate project risks, prepare teams for agency meetings, and lead responses to regulatory queries from global health authorities.