Regulatory Affairs Associate - Mobile Alabama

Company: VirtualVocations
Location: Mobile, Alabama
Posted On: 02/07/2025

A company is looking for a Regulatory Affairs Associate responsible for managing and compiling CMC sections of marketed product variations.



Key Responsibilities

Manage and compile CMC sections for marketed product variations, ensuring timely submission document preparation
Coordinate activities with functional departments to support regulatory filings and develop project timelines
Facilitate project team meetings and ensure thoroughness, accuracy, and timeliness of CMC dossiers


Required Qualifications

Bachelor's Degree in a Science-related field
4 years of experience in the pharmaceutical industry, with 1-2 years in cross-functional project management
Preferred 5 years of pharmaceutical experience, including 1-2 years in regulatory affairs or related fields
Experience with regulatory submission documentation and electronic document management systems
Familiarity with US and international regulatory requirements for dossiers More...

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