Director of US Regulatory Affairs
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
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
