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CMC Regulatory Manager – Generics & Sterile Injectables
Job in
Berkeley Heights, Union County, New Jersey, 07922, USA
Listed on 2026-08-22
Listing for:
Breckenridge Pharmaceutical Inc
Full Time
position Listed on 2026-08-22
Job specializations:
-
Healthcare
Healthcare Management -
Management
Healthcare Management
Job Description & How to Apply Below
Breckenridge Pharmaceutical Inc. in Berkeley Heights, NJ is seeking a Manager Regulatory Affairs to lead regulatory CMC strategies for generic drugs, including sterile injectables and drug-device combinations.
The role partners with the Director of Regulatory Affairs to prepare high-quality filings and ensure FDA compliance. You will coordinate submissions, support due diligence for business development, guide cross-functional teams, and mentor junior staff while navigating 21 CFR rules, eCTD
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