Compliance Advisor II supporting enterprise - wide compliance operations at AltaMed. Involves audits, training, policy drafting, and compliance queries with healthcare focus.
About the role
- Senior Specialist in Regulatory Affairs handling licensing and compliance for pharmaceutical products. Collaborating with various departments to meet regulatory requirements and maintain standards.
Responsibilities
- 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
Job title
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