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Associate Director Regulatory Affairs

Company: VirtualVocations
Location: Bridgeport
Posted on: November 17, 2024

Job Description:

A company is looking for an Associate Director, Regulatory Affairs and Submissions.



Key Responsibilities

Provide regulatory guidance to sponsors regarding drug development and submission requirements
Lead the preparation and submission of regulatory documents, including INDs and meeting requests
Collaborate with cross-functional teams to ensure high-quality submissions and compliance with regulations


Required Qualifications and Education

MSc/MS or PhD in a relevant field
5+ years of US regulatory experience in an industry setting
Strong knowledge of drug development and regulatory policies, particularly ICH, FDA, and Health Canada guidelines
Demonstrated experience with leading IND submissions in the US
Experience with Health Canada is an asset

Keywords: VirtualVocations, Stratford , Associate Director Regulatory Affairs, Executive , Bridgeport, Connecticut

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