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Senior CMC Regulatory Lead; Hybrid – Authoring Expert
Job in
Hackensack, Bergen County, New Jersey, 07601, USA
Listed on 2026-02-15
Listing for:
Medix™
Full Time
position Listed on 2026-02-15
Job specializations:
-
Healthcare
Healthcare Administration, Healthcare Management
Job Description & How to Apply Below
A leading healthcare staffing agency is looking for a Senior Regulatory Affairs Associate in New Jersey. In this hybrid position, the successful candidate will draft and manage CMC Module 3 for complex generics and sterile injectables. Candidates must possess at least 5 years in Regulatory Affairs, with proven experience in Small Molecule Generics, and the ability to lead submissions.
This role offers visibility within the organization, a hybrid work model, and opportunities for professional development.
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Position Requirements
10+ Years
work experience
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