Regulatory Affairs Associate - Labelling

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

Additional Information:

• You will be working within a dynamic team environment while maintaining autonomy in your area of competence.

• There will be opportunities for professional development and growth within the organization.

• The successful candidate may occasionally serve as a Project Lead or a Work Stream Lead.

• Excellent organizational skills and attention to detail are necessary to excel in this role.

• This is a full-time position within our organization.

If you are a highly organized and detail-oriented professional with a strong background in change control management and labelling processes, we encourage you to apply. Join Parexel and contribute to our mission of improving patient lives through clinical research!