Senior Specialist Regulatory Affairs CMC

Lavipharm is seeking a Senior Specialist Regulatory Affairs CMC who will be accountable for ensuring the appropriate licensing and maintenance of assigned products and development projects in line with company business objectives, relevant CMC regulatory requirements and internal and external standards.

Job Responsibilities

The ideal candidate will

• 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
• BSc in a relevant area is required. Master of Science Degree (M.Sc.) is optional
• 3-5 years Regulatory Affairs experience in CMC RA Department of a pharmaceutical company
• Excellent Knowledge of the Greek & English language
• Computer literacy