Regulatory Affairs Executive

Uniza Group

0 years

0 Lacs

ahmedabad gujarat india

Posted:1 day ago| Platform:

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Skills Required

qc packaging tracking labeling support audits query strategy analysis documentation

Work Mode

On-site

Job Type

Full Time

Job Description

Prepare, review, and compile dossiers (CTD/eCTD/ACTD formats) for submission to regulatory authorities in domestic and international markets.
Coordinate with R&D, QA, QC, Production, and Packaging teams to collect required technical documents for registration.
Handle new product registration, re-registration, and post-approval variations.
Maintain and update product registration databases and regulatory tracking sheets.
Review artwork, labeling, and packaging material to ensure regulatory compliance.
Support regulatory inspections and audits by authorities or clients.
Communicate with regulatory agencies or distributors for query resolution.
Stay updated with changes in global regulatory guidelines (USFDA, EMA, MHRA, WHO, TGA, etc.).
Participate in internal regulatory strategy discussions for product development.
Review of the technical documents like BMR, Specification, Method of analysis, COA for Raw material, packing material and finished product
Maintain the FDA license documentation like Product permission, CoPP, FSC and related expenses

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