Regulatory Affairs Associate - Labelling

at  Parexel

Parexel, a leading Clinical Research Organization, is seeking a Regulatory Affairs Associate (Labelling) to join our team. As a Regulatory Affairs Associate, you will be responsible for managing and coordinating text and artwork changes, ensuring compliance with regulatory requirements and global labeling standards. This is a crucial role in ensuring the efficient and accurate implementation of labeling updates across various regions.
The role can be home or office based in various European locations.

JOB RESPONSIBILITIES:

• Track the status of ongoing changes to labelling/artwork projects, evaluating regulatory impact when applicable
• Document changes and identify countries potentially impacted by the change
• Assign Regulatory Affairs Reviewer and Assessment Coordinator(s) to manage changes from initiation to closure
• Utilize document management tools to streamline change control processes
• Maintain familiarity with the Company Core Datasheet (CCDS) and its implementation into labelling and artworks
• Collaborate with cross-functional teams to ensure smooth coordination between labelling and artwork processes
• Demonstrate knowledge of regulatory requirements for labelling updates in different regions, including EU, US, and APAC
• Appreciate the relationship between labelling and artwork processes

SKILLS AND EXPERIENCE REQUIRED FOR THE ROLE:

• University Degree in a Scientific or Technical Discipline
• Around 2 years of experience in an industry-related environment
• Preferably possess knowledge of SmPC, PIL, and QRD requirements
• Exercise good organization skills to effectively manage multiple activities simultaneously
• Prior experience using Trackwise is a plus
• Client-focused approach to work
• Strong interpersonal and intercultural communication skills, both written and verbal
• Critical thinking and problem-solving abilities
• Proficiency in English written and spoken