ROLE
– Prepare, review, and submit CTD / ACTD / country-specific dossiers for new product registrations, line extensions, variations, and renewals
– Coordinate compilation of Modules 1–5 with QA, QC, R&D, CMC, Pharmacovigilance, and Manufacturing teams
– Ensure dossier compliance with WHO, ICH, and local authority guidelines
– Develop registration strategies for RoW markets considering country-specific regulations
– Support business development by providing regulatory feasibility and timelines for new markets/products
– Assess regulatory impact for formulation/site changes
– Manage post-approval changes, including CMC variations, labeling updates, and artwork changes
– Track and ensure timely renewals/re-registrations
– Maintain approved product documentation and regulatory databases
– Handle deficiency letters/queries from regulatory agencies
– Prepare responses in coordination with internal stakeholders
– Liaise with local agents, consultants, and partners for RoW countries
– Monitor regulatory guideline updates for RoW markets
– Ensure submissions comply with the latest country requirements
– Support internal audits, regulatory inspections, and due-diligence audits
– Mentor junior team members and review their regulatory work
– Track regulatory milestones and ensure alignment with project timelines
– Participate in cross-functional meetings for project planning and risk assessment