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Associate Director, Regulatory Affairs

Company: VirtualVocations
Location: Jacksonville
Posted on: March 12, 2025

Job Description:

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

Provide regulatory guidance to sponsors on drug development and submission requirements
Lead the preparation and submission of regulatory documents and manage interactions with health authorities
Coordinate team workload and supervise staff on various projects

Required Qualifications

BSc/MSc in a relevant field with 7+ years of US regulatory experience
Strong knowledge of drug development and regulatory policies, including ICH and FDA guidelines
Experience leading IND submissions in the US; familiarity with other regulatory agencies is a plus
Knowledge of CMC drug development requirements is advantageous
Demonstrated leadership skills and ability to work collaboratively with cross-functional teams

Keywords: VirtualVocations, Jacksonville , Associate Director, Regulatory Affairs, Executive , Jacksonville, Florida

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