Global Regulatory Strategy Lead

Kardigan; Princeton (NJ); Sur place; USD 266 000 - 346 000; Plein temps

Résumé du poste

Kardigan seeks an Executive Director, Regulatory Strategy to lead global regulatory strategy for our cardiovascular portfolio. Reporting to the SVP, Regulatory Affairs, you will own development and execution of regulatory plans and serve as the primary interface with the FDA, guiding ex-US activities with partners.

This high‑ownership role shapes regulatory pathways for late‑stage therapies, builds a scalable regulatory function, and drives risk assessment, submissions (INDs/CTAs/NDAs/MAAs), and

Qualifications

• Bachelor of Science in a scientific discipline.
• 10+ years in pharmaceutical regulatory activities with global strategy leadership.
• Experience leading regulatory submissions (INDs/NDAs/MAAs) and Health Authority interactions.

Responsabilités

• Lead development and execution of regulatory strategy for late‑stage programs.
• Interface with stakeholders to implement cross‑portfolio global strategies.
• Serve as primary FDA contact and manage ex-US activities with partners.
• Prepare and execute health authority meetings and submissions.
• Oversee regulatory documents, logs, and compliance.
• Provide regulatory input across clinical development plans and labeling.
• Hire, develop, and mentor regulatory professionals.

Formation

Bachelor of Science in a scientific discipline

Description du poste

Kardigan seeks an Executive Director, Regulatory Strategy to lead global regulatory strategy for our cardiovascular portfolio. Reporting to the SVP, Regulatory Affairs, you will own development and execution of regulatory plans and serve as the primary interface with the FDA, guiding ex-US activities with partners.

This high‑ownership role shapes regulatory pathways for late‑stage therapies, builds a scalable regulatory function, and drives risk assessment, submissions (INDs/CTAs/NDAs/MAAs), and