CEE Regulatory Affairs Specialist

Job Summary

To support regulatory and pharmacovigilance activities, the full-time CEE Regulatory Affairs Specialist will manage regulatory applications, safety monitoring, and compliance tasks for medicinal and non-medicinal products across various countries, working both independently and collaboratively with senior staff.

Key responsibilities

• Prepare regulatory applications and supporting documentation for marketing authorizations and product recalls
• Monitor local and EU legislation, ensuring compliance in regulatory and pharmacovigilance activities
• Collect and assess safety reports, maintaining documentation and communication with healthcare professionals and partners

Required qualifications

• B.Sc./B.A. or higher degree in medicine, pharmacy, dental medicine, or medical biochemistry
• Advanced knowledge of local and EU regulatory legislation and experience with regulatory submissions
• Experience in pharmacovigilance and safety monitoring activities
• Ability to manage multiple tasks and prioritize effectively in a fast-paced environment
• Intermediate to advanced English language proficiency, both verbal and written