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Senior Regulatory Affairs Associate - Artwork (home or office based)
Primary Location: Romania, Bucharest Additional Locations: Croatia, Remote; Croatia, Zagreb; Czech Republic, Prague; Czech Republic, Remote; Hungary, Budapest; Hungary, Remote; Poland, Remote; Poland, Warsaw; Romania, Remote; Serbia, Belgrade; Serbia, Remote Job ID R0000035628 Category Regulatory Affairs Date Posted 09/17/2025Overview
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 an experienced Senior Regulatory Affairs Associate - Artwork Strategist to develop and execute artwork strategies for our global product portfolio. In this critical role, you will ensure comprehensive oversight throughout the product lifecycle while serving as the primary liaison between Regulatory Affairs and various stakeholders.
The role can be home or office based in various European locations.
Role Responsibilities:
Strategic Leadership
Develop and execute artwork implementation strategies for global product portfolios
Serve as the main point of contact for Regulatory Affairs, proactively addressing planning requirements and CAPA-related artwork issues
Create and maintain global product portfolio plans, including change assessments in collaboration with Artwork operations
Build internal and external networks, conduct benchmarking, and stay informed about relevant regulations
Develop grouping and Mock-up strategies while overseeing the Mock-up process
Change Proposal Management
Ensure project management for artwork-related projects, including tracking change proposals
Provide change proposal references to requestors and plan project kick-off meetings
Verify first batches with new printed components/artworks are used in production
Document first released batches with new artworks
Artwork Project Management
Create and schedule artwork projects
Coordinate and track artwork creation and approval processes
Create and manage Mock-Up projects in artwork management systems
Skills and Experience required for the role:
Bachelor's Degree in a Scientific or Technical Discipline
3-5 years of experience in an industry-related environment
In-depth understanding of pharmaceutical industry regulations, particularly in Regulatory and Supply Chain
Comprehensive knowledge of end-to-end Labeling & Artwork activities
Strong project management capabilities
Client-focused approach with results orientation
Excellent teamwork and collaboration abilities
Critical thinking and problem-solving aptitude
Fluent in English written and spoken
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