Regulatory Affairs Generalist
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Job Description
Regulatory Affairs Professional supporting global regulatory teams in compliance with health authority requirements. Involves managing licenses and documentation within the product lifecycle.
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
Requirements:
- 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.
Benefits:
- Professional development opportunities
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