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6.0 - 11.0 years
6 - 8 Lacs
ahmedabad
Work from Office
Job Title: Senior Regulatory Executive RoW Market ( LATAM Specially) Location: Ahmedabad Experience: 5–7 years in Regulatory Affairs (RoW markets) Qualification: B.Pharm / M.Pharm / Life Sciences Key Responsibilities: Prepare & review CTD/eCTD/non-CTD dossiers for new registrations, renewals, and variations. Coordinate with agents/distributors for submissions and query responses. Track timelines and ensure compliance with regulatory guidelines (LATAM, Africa, CIS, Asia). Manage product lifecycle: variations, renewals, packaging/labelling updates. Maintain regulatory databases and trackers. Key Skills: Strong knowledge of RoW regulatory requirements & dossier formats. Experience with LATAM countries (Brazil, Mexico, Argentina, Chile, etc.). Excellent documentation, coordination & communication skills. Proficiency in MS Office & regulatory databases. Other Details: Will lead a team of 4 RAs and report to Director. Immediate joiners preferred (short notice period).
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