Regulatory Affairs Specialist

Job Summary

To support regulatory and pharmacovigilance activities, the full-time Regulatory Affairs Specialist will manage the preparation of regulatory applications, ensure compliance with local and EU legislation, and provide consultancy to partners while working in Montenegro.

Key responsibilities

• Prepare regulatory applications and supporting documentation for marketing authorizations and product maintenance
• Monitor local and EU pharmacovigilance legislation, managing Individual Case Safety Reports (ICSRs) and safety information
• Provide training and support to regulatory and pharmacovigilance personnel, ensuring compliance with relevant procedures

Required qualifications

• B.Sc./B.A. or higher degree in medicine, pharmacy, dental medicine, medical biochemistry, veterinary medicine, or life/nature science
• At least two years of experience in regulatory affairs
• Advanced knowledge of local legislation for regulatory activities in relevant countries
• Experience with European and national regulatory submissions and agency interactions
• Intermediate to advanced English language proficiency (both verbal and written)