Job Description
Job Responsibility and key Decisions
Support the preparation, review, and submission of registration dossiers and lifecycle management filings for emerging market countries.
Collaborate with global and local regulatory teams to gather, compile, and format documentation as per countryspecific requirements.
Track submission timelines, approvals, and health authority queries, ensuring timely updates in internal systems.
Assist in managing countryspecific labeling requirements, renewals, and variations.
Maintain proper documentation and ensure inspectionaudit readiness of regulatory files.
Support query responses from health authorities in collaboration with senior regulatory personnel or affiliates.
Monitor changes in regulatory requirements through internal resources and update templates or checklists accordingly.
Key Decisions
Identify missing or outdated documents in regulatory dossiers and notify the responsible stakeholders.
Suggest improvements to submission tracking or document filing processes.
Prioritize assigned tasks to meet submission and approval deadlines, with guidance from team leads.