Job for Regulatory Affairs Executive-Reputed Pharma Industry-Chennai, Tamilnadu, India-12LPA-E102

JOB DETAILS

Manages, reviews, and authors regulatory submissions, including new ANDA filings, complete response letters (CRLs), information requests (IRs), and amendments to existing ANDAs.

Responsible for filing Post-Approval and Prior Approval Supplements in compliance with FDA requirements.

Reviews change controls to assess regulatory impact and ensure alignment with applicable FDA regulations and guidance.

Performs eCTD compilation and electronic submission of ANDAs and USDMFs.

FUNCTIONAL AREA

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