Regulatory Affairs Specialist

4 tygodni temu

Warszawa, Mazovia, Polska Parexel Pełny etat

Parexel is seeking a Regulatory Affairs Associate (Labelling) to support our team.

The successful candidate will be responsible for managing and coordinating text and artwork changes, ensuring compliance with regulatory requirements and global labeling standards.

Key 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

Requirements:

  • 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

About the Role:

The Regulatory Affairs Associate will work within a dynamic team environment while maintaining autonomy in their 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.

This is a full-time position within our organization.

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