Regulatory Affairs Associate - Labelling & Artwork
Romania, Remote Additional Locations Belgrade,Serbia;Bucharest,Romania;Budapest,Hungary;Prague,Czechia;Warsaw,Poland;Warszawa,Poland;Zagreb,Croatia Job ID R0000031997 Category Consulting Date Posted 03/12/2025Overview
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
Are you passionate about regulatory affairs and project management in the pharmaceutical industry? Do you have a keen eye for detail and a talent for strategic planning? Parexel is seeking a dynamic Regulatory Affairs Associate to join our Labelling & Artwork team!
About the Role: As a Regulatory Affairs Associate focusing on Secondary Packaging & Artwork, you will play a crucial role in ensuring our clients' products meet regulatory requirements and market standards. You will be responsible for developing and implementing artwork strategies, managing global product portfolios, and serving as a key liaison between various stakeholders.
Key Responsibilities:
Develop and oversee secondary packaging and artwork strategies for assigned product portfolios
Generate and maintain global product portfolio plans, including capacity and budget requirements
Act as a regulatory expert and ambassador for artwork implementation
Collaborate with cross-functional teams, including Regulatory Affairs, Supply Chain, and Technical Operations
Drive continuous improvement in processes and tools related to secondary packaging and artwork
Ensure compliance with regulatory requirements and internal processes
Manage change controls, deviations, and investigations related to packaging and artwork
Provide training and support to staff on artwork strategy and processes
Skills and Qualifications:
University degree in a Scientific or Technical Discipline
Few years of experience in a related pharmaceutical industry role
Strong knowledge of regulatory affairs, particularly in packaging and labeling
Excellent project management skills
Proficiency in local language and extensive working knowledge of English
Outstanding interpersonal and communication skills
Ability to work effectively in a team environment and independently
Strong problem-solving and critical thinking skills
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