CMC Regulatory Project Manager & Writer
Listed on 2026-10-12
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Business
Regulatory Compliance Specialist
Katalyst CRO is seeking an experienced CMC Writer/Project Manager to support regulatory submissions and deliver high-quality documentation for global health authorities. The role combines technical writing with project management to drive CMC deliverables across drug development programs.
Responsibilities include authoring and reviewing CTD/eCTD sections, managing timelines, coordinating AR/DSUR docs, ensuring FDA/EMA/ICH alignment, and collaborating with cross-functional teams to mitigate
The CMC Regulatory Project Manager & Writer position in the Legal, Management & Operations field is open for applications.
Please review the full job details above before applying.
If your experience matches this role, we encourage you to apply.
All applications are reviewed carefully by our team.
The position is based in Paramus, NJ, United States.
This opportunity is part of our work in Legal, Management & Operations.
The advertised compensation is 120..
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