Regulatory Specialist Jobs

Regulatory Specialist

Novitium Pharma

Location:
United States, East Windsor

Category:
Pharmacy

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

Regulatory Specialist (East Windsor, NJ) (Multiple Openings).

Job Responsibility:

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:

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

Additional Information:

Job Posted:
December 10, 2025

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