Regulatory Affairs Associate Director

A company is looking for an Associate Director, Regulatory Affairs - Contract.

Key Responsibilities

Serve as the regulatory representative for drug development project teams, contributing to regulatory strategies and requirements

Manage, plan, coordinate, and prepare regulatory submission documents for U.S. and international authorities

Interact directly with regulatory agencies and contribute to pharmacovigilance activities as needed

Required Qualifications

Bachelor's or Master's degree required

Minimum of 10 years of experience in drug development / regulatory affairs in the biopharmaceutical industry

Experience with drug development and commercial product regulatory requirements

Familiarity with eCTD and experience in preparing regulatory submissions is required

Deep knowledge of FDA regulations is required