Regulatory Affairs Generalist (home or office based)

This a Full Remote job, the offer is available from: Hungary, Poland, Romania, Czechia, Croatia, Serbia, reputed company (USA) reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. We are seeking a dedicated Regulatory Affairs reputed company 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 reputed company assessments for technical changes affecting marketing authorizations • Stay reputed company on regulatory requirements and guidelines to ensure compliance • Support health authority inspections as needed • reputed company technical and business consulting services reputed company area of expertise • Complete activities reputed company project scope, reputed company, 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-reputed company environment • Experience in regulatory authority-facing roles • Regulatory Operations (Submission management) experience • Experience using reputed company 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 This offer from "reputed company" has been enriched by reputed company.com and got a 85% reputed company score. Apply tot his job Apply To this Job