Regulatory Documentation Specialist
Company: VirtualVocations
Location: Kansas City
Posted on: April 1, 2025
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Job Description:
A company is looking for a Regulatory Documentation Specialist
responsible for managing documentation activities for regulatory
submissions related to cell therapy brands.
Key Responsibilities
Manage document preparation for CMC regulatory submissions ensuring
compliance with formatting requirements
Coordinate reviews and facilitate meetings within the authoring
system for 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
experience, or a Master's degree with 1-3 years of experience
Working knowledge of regulatory CMC submissions, with experience in
Cell Therapy preferred
Ability to work independently and collaboratively in a team
environment
Strong time management and organizational skills
Flexibility to manage multiple projects in a fast-paced
environment
Keywords: VirtualVocations, Kansas City , Regulatory Documentation Specialist, Other , Kansas City, Kansas
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