Regulatory Affairs Generalist (home or office based)

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
  
  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
  
  At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.