Senior Director of Regulatory Affairs

A company is looking for a Senior Director, Regulatory Affairs.

Key Responsibilities

Represent regulatory on cross-functional teams and provide leadership for regulatory deliverables

Lead planning and support the development of global regulatory submission documents

Serve as primary contact with Health Authorities and maintain expert knowledge in regulations

Required Qualifications

Bachelor's degree with a minimum of 10 years of experience in Regulatory Affairs

Demonstrated successful interactions with FDA and other Health Authorities

Expert understanding of global drug development principles and regulatory requirements

Experience in preparing regulatory filings, including IND / CTAs and briefing documents

Strong project management skills and ability to work in a dynamic environment