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Regulatory Specialist

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East Windsor, United States Novitium Pharma Full time

Regulatory Specialist (East Windsor, NJ) (Multiple Openings). Review, manage and write regulatory submissions electronically which include New ANDA filings, Complete Response letters, Information requests, Amendments to the ANDA’s (Labeling, Chemistry & Bioequivalence) of different dosage forms (Tablet, Capsule, Liquid & Solutions); responsible for filing the Post Approval Supplements like CBE-0, CBE-30 (Changes being effective in 30 days) and Prior Approval Supplements (PAS); submitting dossiers electronically after the approval of initial product submissions (ANDA); review of the leachable and extractable reports generated for the oral Liquid & Solution drug products. Must have bachelors in Pharmaceutical sciences / biology / microbiology / chemistry / chemical / Regulatory Affairs / Related + 1 year exp. as Regulatory Specialist /Quality Control Analyst / Chemist / Analyst / Scientist/ Research Associate / Related. Respond to HR Manager, Job ID # RS-24, Novitium Pharma LLC, 70 Lake Drive, East Windsor, NJ 08520.