I contribute to clinical research with expertise and empathy. And I do it
Regulatory Affairs Generalist (home or office based)
Primary Location: Romania, Bucharest 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 Job ID R0000037406 Category Regulatory Affairs Date Posted 12/10/2025Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
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
Employee Insights
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