Director of Regulatory Affairs

A company is looking for a Director, Regulatory Project Management to lead the end-to-end project management of a New Drug Application (NDA) submission.

Key Responsibilities

Develop and maintain a comprehensive NDA submission project plan, ensuring timely execution and alignment with corporate objectives

Establish governance forums and facilitate cross-functional collaboration to manage risks and track submission progress

Oversee FDA interactions and manage post-submission transitions, ensuring compliance with regulatory requirements

Required Qualifications

Bachelor's degree in life sciences, pharmacy, or a related discipline; advanced degree preferred

10+ years of experience in the pharmaceutical / biotech industry with a focus on regulatory project management

Demonstrated leadership in managing at least one NDA or BLA submission from initiation to completion

Deep knowledge of FDA regulations, ICH guidelines, and CTD / eCTD structure

Proficiency with project management methodologies and tools