Regulatory Affairs Generalist (home or office based)
Bucharest, Bucureşti, Romania Additional Locations: Croatia, Remote; Croatia, Zagreb; Czech Republic, Prague; Czech Republic, Remote; Hungary, Budapest; Hungary, Remote; Lithuania, Remote; Lithuania, Vilnius; Poland, Remote; Poland, Warsaw; Romania, Remote; Serbia, Belgrade; Serbia, Remote 职位编号 R0000037406 类别 Consulting关于这个职位
We are seeking a dedicated Regulatory Affairs Professional to join our growing team. This role offers an opportunity to work with global and local regulatory teams, supporting product lifecycle management and ensuring compliance with health authority requirements. The role can be home or office based in various European locations.
Role Responsibilities:
Support global and/or local regulatory teams with comprehensive understanding of regional and global regulatory requirements
Manage post-authorization lifecycle maintenance procedures (variations, renewals, PSURs) for multiple licenses
Coordinate health authority interactions and responses to questions
Prepare and organize local-specific documentation (Module 1) to meet national submission requirements
Maintain up-to-date local national systems according to local legislation
Manage impact assessments for technical changes affecting marketing authorizations
Stay current on regulatory requirements and guidelines to ensure compliance
Support health authority inspections as needed
Provide technical and business consulting services within area of expertise
Complete activities within project scope, timeline, and objectives
Skills and Experience required for the role:
University Degree in a Scientific or Technical Discipline
A few years of experience in an industry-related environment
Experience in regulatory authority-facing roles
Regulatory Operations (Submission management) experience
Experience using Veeva Vault RIMS - strong plus
Outstanding interpersonal and intercultural communication skills (written and verbal)
Critical thinking and problem-solving abilities
Fluent in English, written and spoken
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