Regulatory Specialist

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.

Requirements:

Bachelor's degree in Pharmaceutical sciences / biology / microbiology / chemistry / chemical / Regulatory Affairs / Related

1 year experience as Regulatory Specialist / Quality Control Analyst / Chemist / Analyst / Scientist / Research Associate / Related

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