Director of US Regulatory Affairs

Job Summary

A company is looking for a Director US Regulatory Affairs Liaison.

Key Responsibilities

• Develops and enacts US regulatory strategies for key projects, ensuring compliance and alignment with business objectives
• Oversees submission materials and guides the review process to ensure quality and compliance with FDA regulations
• Leads FDA communications and negotiations to secure timely product approvals and optimal labeling

Required Qualifications

• US FDA regulatory experience in related drug or device area
• Demonstrated team leadership and ability to foster a positive work culture
• In-depth knowledge of the US regulatory affairs environment and FDA relationship management
• Exceptional project management skills with the ability to handle multiple issues under time pressure
• Strong ability to manage ambiguity and solve complex business and regulatory issues