Senior Regulatory Affairs Associate
Current• Provide regulatory support to clients and associate companies. • Handling of Pre-Licensing ,New Registration Submission (RA Strategy) and post licensing submission activities via Veeva Vault.• Provide support and review for Linguistic review (LR) process on PI information for CP and MRP procedures.• Coordinate with GRA Lead for submission requirements and timely submission via Veeva Vault.• Handling M1 related documentation for DCP/MRP/NP Submission Management.• Managing client administrative documents and reports.• Compilation of regulatory dossiers in accordance with national requirements.• Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling based on QRD.• Document and track regulatory submissions and regulatory authority approval.• Search, extract, evaluate, compare data according to needs.• Proper e-Archival all of the file to respective folder.• Review of Mock ups as per EU requirements during the submission of dossiers• Provide on-going regulatory support to the Regulatory Affairs Specialist and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.• Contribute to data entry in PLG tools enabling measurements of KPI and metrics for regulatory services supplied by the platform/hub
