Regulatory Affairs Generalist

• 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

• 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

Experience using Veeva Vault RIMS

• Flexible work arrangements
• Opportunities for career growth
• Supportive and inclusive environment
• Diverse and global client exposure
• Learn from experts