Sr. Spclst, Regulatory Affairs

Execute local regulatory affairs processes in alignment with RA systems, quality management systems, and department SOPs. Prepare and submit new Marketing Authorization Applications to local Health Authorities while maintaining authorized products through post-market regulatory dossiers, including variations and renewals. File, store, and archive safety-related data and documentation in accordance with local requirements. Support local audits and inspections, develop corrective and preventative actions for non-compliance issues, and conduct vendor qualification audits. Develop local procedures to ensure data quality and identify procedural gaps for improvement. Liaise with business units on safety activities and strategic decisions such as new clinical trials and product launches. Manage regulatory licenses for import and distribution, and support drug shortage management and risk minimization measures.