SALARY
: up to 12 LPA
LOCATION
: Chennai, Tamilnadu, India
VACANCIES
: 2
QUALIFICATION
: Any Graduate
MALE/FEMALE
: Both
EXPERIENCE
: 7 years and above

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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