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Healthcare Management

Strategic CMC Regulatory Project Manager

Job in Paramus, Bergen County, New Jersey, 07653, USA
Listing for: Katalyst CRO
Full Time position
Listed on 2025-12-10
Job specializations:
  • Management
    Healthcare Management
  • Healthcare
    Healthcare Management
Job Description & How to Apply Below
A leading clinical research organization is seeking an experienced CMC Writer / Project Manager to support regulatory submissions. This role combines technical writing expertise with project management skills to ensure timely, high-quality documentation for global health authorities. Responsibilities include authoring CMC sections of submissions, managing timelines, and ensuring compliance with regulations. Ideal candidates have at least 5 years of relevant experience and a Bachelor's or advanced degree in Chemistry or Pharmaceutical Sciences.
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