Senior Regulatory Affairs Associate – Complex Generics
Job in
Berkeley Heights, Union County, New Jersey, 07922, USA
Listed on 2026-08-03
Listing for:
Breckenridge Pharmaceutical
Full Time
position Listed on 2026-08-03
Job specializations:
-
Pharmaceutical
Job Description & How to Apply Below
Breckenridge Pharmaceutical, Inc. in the United States, seeks a Regulatory Affairs Senior Associate to manage regulatory submissions (ANDAs and post-approval changes), support lifecycle management, and assist the Director of Regulatory Affairs.
Focus on complex generics and drug-device combinations. You will author eCTD sections, prepare meeting packages under GDUFA III, coordinate with internal teams and external partners, and contribute to development from early formulation to final filing,
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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