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CMC Regulatory Specialist

Company: VirtualVocations
Location: Mesquite
Posted on: March 22, 2025

Job Description:

A company is looking for a CMC Regulatory Specialist to manage documentation activities for regulatory submissions related to cell therapy brands.



Key Responsibilities

Manage document preparation for CMC regulatory submission documents to ensure compliance with formatting requirements
Coordinate reviews and facilitate consensus meetings within the authoring system for CMC regulatory submissions
Participate in cross-functional project teams and interact with technical subject matter experts and regulatory partners


Required Qualifications

Bachelor's degree in a relevant discipline with 4-7 years of relevant experience, or a Master's degree with 1-3 years of relevant experience
Working knowledge of regulatory CMC submissions, with experience in Cell Therapy being a plus
Ability to work independently and collaboratively in a team environment
Excellent time management and organizational skills
Flexibility to manage multiple projects in a fast-paced environment

Keywords: VirtualVocations, Mesquite , CMC Regulatory Specialist, Other , Mesquite, Texas

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