The Role
Prepare and maintain CMC regulatory dossiers (CTD Module 3 and Module 2.3), ensure compliance with relevant regulations, implement RA policies, maintain regulatory databases and filing systems, coordinate with R&D/Quality/Operations, and provide CMC regulatory support across departments.
Summary Generated by Built In
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
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
Skills Required
- BSc in a relevant area
- Master of Science (MSc)
- 3-5 years Regulatory Affairs experience in CMC RA department of a pharmaceutical company
- Experience in CMC writing and compilation of CTD Module 3 and Module 2.3 (Quality Overall Summary)
- Excellent knowledge of Greek and English
- Computer literacy
- Maintains up-to-date knowledge of relevant regulations and regulatory databases/filing systems
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The Company
What We Do
Lavipharm SA is a Greek pharmaceutical company that develops, manufactures, markets, and distributes pharmaceutical, cosmetic, veterinary, and consumer health products. It is recognized for its expertise in Transdermal Drug Delivery Systems (TDDSs) and has a significant international presence.
