Brooks Laboratories, a leading pharmaceutical manufacturer excelling in General Injectable, Liquid and Dry Powder Inj., B lactam (Tablets, Injections & Suspension)., Eye Ear Drops Our WHO GMP accredited facility is recognized by regulatory bodies in Nigeria, Cambodia, Ivory Coast, Yemen, Vietnam, Syria and D R Congo ensuring the highest quality standards.
Post : Officer / Sr. Officer or Team Leader
Department : Regulatory Affairs - API
Educational Qualification : B.Pharma / M.Pharma
Total Experience : 2-5 years or 7-10 years
Job Description
• Strong experience in ROW markets. The role involves handling initial submissions, deficiency management, post-approval variations and lifecycle management activities in compliance with global regulatory requirements.
• Preparation, compilation, and submission of dossiers for ROW markets
• Building submissions that are compliant with CTD/eCTD/ACTD formats
• Coordinate with cross-functional teams (R&D, QA, QC, Manufacturing) for document collection and facilitate discussions for query resolution
• Maintain regulatory trackers, databases, and archives
• Handling filings of post approval variations
• Manage renewals & annual reports
• Track submission timelines and approvals.
• Handle deficiency responses and queries from regulatory authorities
• Review labelling components as per regional requirements
Share your CV at preeti.yadav@brookssteriscience.com
Brooks Steriscience Limited
Block No 61/62, Village Manglej ,Nareshwar Road,
Tal : Karjan, Dist: Vadodara, Gujarat- 391243
Last Date : 30th June 2026
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