Global Regulatory Strategy Director

Regulatory Jobs; Princeton (NJ); On-site; USD 266,000 - 346,000; Full time

Job summary

Kardigan seeks an Executive Director, Regulatory Strategy to lead global regulatory strategy across cardiovascular therapies. Reporting to the SVP, Regulatory Affairs, you will own the development and execution of regulatory strategy in line with the integrated development plan and act as the primary interface with the FDA while directing ex-U.S.

activities with consultants and partners. This high-ownership role will help define regulatory pathways, build regulatory capabilities, and manage core

Qualifications

• Bachelor of Science in a scientific discipline.
• Experience leading global regulatory product strategy.
• Extensive experience with regulatory submissions (INDs/NDAs/MAAs) and health authority interactions.
• Ability to lead cross-functional teams and manage external partners (CROs, vendors).

Responsibilities

• Lead development and execution of global regulatory strategy for late-stage programs.
• Interface with FDA and oversee ex-U.S. activities with partners.
• Mentor regulatory professionals and align regulatory plans with development programs.

Skills

Regulatory strategy

Global regulatory

FDA liaison

Regulatory submissions

Team leadership

Education

Bachelor of Science in a scientific discipline

Advanced degree (preferred)

Job description

Kardigan seeks an Executive Director, Regulatory Strategy to lead global regulatory strategy across cardiovascular therapies. Reporting to the SVP, Regulatory Affairs, you will own the development and execution of regulatory strategy in line with the integrated development plan and act as the primary interface with the FDA while directing ex-U.S.

activities with consultants and partners. This high-ownership role will help define regulatory pathways, build regulatory capabilities, and manage core