Job Description
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
regulatory affairs jobs in india, regulatory affairs jobs in chennai, regulatory affairs jobs in tamil nadu, pharma industry jobs in chennai
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