Job for Regulatory Affairs Executive-Reputed Pharma Industry-Chennai, Tamilnadu, India-12LPA-E102
1 week ago
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 Pharma Jobs Consultancy in Chennai, Pharma Jobs Consultancy near me, Pharma Jobs, Top, Best, Jobs Consultancy in Chennai, regulatory affairs jobs in india, regulatory affairs jobs in chennai, regulatory affairs jobs in tamil nadu, pharma industry jobs in chennai Apply Now
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Chennai, India Seven Consultancy Full timeJOB DETAILS Candidates should review and prepare regulatory submissions, including new ANDA filings, amendments and Annual reports to the ANDA.Review of DMF Manages USFDA registration activities FUNCTIONAL AREA Pharma Jobs Consultancy in Chennai, Pharma Jobs Consultancy near me, Pharma Jobs, Top, Best, Jobs Consultancy in Chennai, regulatory affairs jobs in...
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