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Regulatory Submissions Specialist - eCTD & FDA Expert
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 Compliance -
Pharmaceutical
Healthcare Compliance
Job Description & How to Apply Below
Breckenridge Pharmaceutical, Inc. in Berkeley Heights, NJ, seeks a Senior Associate, Regulatory Operations to lead US regulatory submissions to the FDA, maintain eCTD templates, and ensure FDA/ICH compliance. You will also manage document workflows and corporate records, enabling timely submissions.
The role requires strong communication skills and 5+ years in pharma regulatory affairs, with 3–4 years in regulatory operations. Competitive benefits and a robust team environment are offered.
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