About The Role

Key Responsibilities 1. Dossier Preparation & Submissions Prepare, review, and submit CTD / ACTD / country‑specific dossiers for: New product registrations Line extensions (strength, pack size, shelf life) Variations and renewals Coordinate compilation of Modules 1–5 with QA, QC, R&D, CMC, PV, PM, and Manufacturing teams. Ensure dossier compliance with WHO, ICH, and local authority guidelines . 2. Regulatory Strategy & Market Support Support business development by providing regulatory feasibility and timelines for new markets/products. Assess regulatory impact for formulation/site changes. 3. Regulatory Lifecycle Management Manage post‑approval changes , including: CMC variations Labeling updates Artwork changes Track and ensure timely renewals/re‑registrations . Maintain approved product documentation and regulatory databases. 4. Health Authority Interaction Handle deficiency letters / queries from regulatory agencies. Prepare responses in coordination with internal stakeholders. Liaise with local agents, consultants, and partners for RoW countries whenever required. 5. Compliance & Intelligence Monitor regulatory guideline updates for RoW markets. Ensure submissions comply with the latest country requirements . Markets Typically Covered (RoW) LATAM : Brazil, Mexico, Colombia, Peru, Chile, Guatemala MENA/GCC region CIS : Russia, Ukraine, Kazakhstan, etc. ASEAN : Philippines, Vietnam, Thailand, Malaysia, etc.

Required Qualifications & Experience • Educational Background: o M.Pharm / B.Pharm • Experience: o 7-9 years in Pharmaceutical Regulatory Affairs