Lavipharm

Compliance

• Evaluate the technical documentation and prepare the technical dossier for different categories of products [i.e. CMC writing and Compilation of Common Technical Document (CTD) Module 3 and Module 2.3 (Quality Overall Summary), required for registration of new pharmaceutical products or variation & renewal applications for existing products], under minimum supervision
• Maintain current knowledge of relevant regulations, including proposed and final rules
• Implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained
• Ensure compliance with the company’s policies and procedures
• Ensure the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department activities
• Work with specialist computer software and resources of the pharmaceutical products/raw material
• Communicate with all departments to ensure and provides properly and effectively any CMC regulatory support as required.
• Co-ordinate with R&D, Quality and Operations teams to ensure compliance to the relevant guidelines

Senior Specialist, Regulatory Affairs CMC