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Associate Director of Regulatory Affairs

Company: VirtualVocations
Location: Beaumont
Posted on: March 7, 2025

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 regulatory submission preparation and conduct agency interactions
Coordinate team workload and supervise staff on a project basis

Required Qualifications

BSc/MSc in a relevant field; 7+ years of US regulatory experience in an industry setting
Strong knowledge of drug development and regulatory policy, including ICH, FDA, and Health Canada guidelines
Demonstrated experience with leading IND submissions in the US
Knowledge of CMC drug development requirements is an asset
Leadership skills and ability to work well with multi-disciplinary teams

Keywords: VirtualVocations, Beaumont , Associate Director of Regulatory Affairs, Executive , Beaumont, Texas

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