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

Regulatory Compliance & CMC Dossier Preparation

• Evaluates the technical documentation and prepares 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
• Maintains current knowledge of relevant regulations, including proposed and final rules
• Implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained
• Ensures compliance with the company’s policies and procedures
  
  

Documentation & Systems Management

• Ensures the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department activities
• Works with specialist computer software and resources of the pharmaceutical products/raw material
  
  

Cross-functional Collaboration & Support

• Communicates with all departments to ensure and provides properly and effectively any CMC regulatory support as required. Co-ordinates with R&D, Quality and Operations teams to ensure compliance to the relevant guidelines
  
  

Other Responsibilities

• Carries out additional responsibilities related to the role as assigned by the Regulatory Affairs & Market Access Director and/or Chief Scientific Officer, ensuring alignment with company goals and vision
  
  

Requirements

• 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
  
  

If you are ready to embark into challenging endeavors, be exposed to continuous learning opportunities, you are interested in the above position and only if you have the required qualifications, please reply, enclosing your curriculum vitae.