VIANEX S.A., the leading pharmaceutical company in Greece is seeking to recruit a CMC Affairs Specialist for the product development and CMC Affairs department at Gerakas Athens.

Responsibilities

• Ensuring that API and Finished Product comply with the relevant EMA requirements & ICH Guidelines.
• DMF evaluation
• Preparation of Variation based on Guidelines of European Commission.
• Compiling (in e-CTD format) the Module 3 of the dossier license application for submissions (DCP, MRP, National Submissions)
• Addressing the Regulatory Bodies΄ Deficiency Letters
• Post approval support of Finished Product dossier (Module 3).

Requirements

• 2 - 5 years of experience in the CMC Regulatory Affairs field
• Bachelors in Pharmacy, Chemistry or Chemical Engineering
• Εxperience in the CMC Regulatory Affairs Field
• Excellent knowledge of English and Microsoft Office

Benefits

• Competitive remuneration package
• Professional development prospects
• Continuous training and excellent working environment