Regulatory Affairs Associate

6 miesięcy temu

Warszawa, Polska Parexel Pełny etat

When our values align, there's no limit to what we can achieve.
 

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

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