I contribute to clinical research with expertise and empathy. And I do it
Regulatory Affairs Professional - Labelling (home or office based)
Primary Location: Romania, Bucharest Additional Locations: Croatia, Remote; Croatia, Zagreb; Czech Republic, Prague; Czech Republic, Remote; Hungary, Budapest; Hungary, Remote; Ireland, Dublin; Ireland, Remote; Italy, Milan; Italy, Remote; Lithuania, Remote; Lithuania, Vilnius; Poland, Remote; Poland, Warsaw; Romania, Remote; Serbia, Belgrade; Serbia, Remote; Spain, Madrid; Spain, Remote; United Kingdom, London; United Kingdom, Remote Job ID R0000037408 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 Labelling professional to join our growing team! This role offers an opportunity to work with global labelling teams, ensuring regulatory compliance and supporting product labelling management across multiple regions.
The role can be home or office based in various European locations.
Role Responsibilities:
Support Global Labelling, Regulatory (Clinical/Safety), or Medical Writing teams for labelling updates
Manage Company Core Datasheet (CCDS) implementation into labelling and artworks
Identify triggers for CCDS updates and coordinate impact assessments for technical changes
Apply knowledge of Safety Signal Management and its impact on labelling
Navigate CCDS governance processes in pharmaceutical environments
Understand Periodic Safety Update Reports (PSUR) and their potential impact on labelling
Manage the relationship between labelling and artwork processes
Implement regulatory processes required to update product labelling (various variation categories)
Prepare Addendum to Clinical Overview (Module 2.5) to support labelling variations
Apply regulatory requirements for labelling updates across different regions (EU, EAEU, US, APAC)
Manage SmPC, PIL and QRD requirements, EU linguistic reviews, and translation activities
Coordinate readability and PIL testing processes
Review and approve consumer-facing materials in accordance with approved labelling
Participate in promotion review committees and provide regulatory guidance for local markets
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
Initial years of labelling/regulatory experience with global responsibilities
Regulatory Operations (Submission management) experience
Outstanding interpersonal and intercultural communication skills (written and verbal)
Critical thinking and problem-solving abilities
Fluent in English, written and spoken
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