Regulatory Affairs Professional

1 week ago

Bucharest, Bucureşti, Romania Parexel Full time

We are seeking a dedicated Regulatory Affairs Labelling professional to join our growing team This role offers an opportunity to work with global labelling teams, ensuring regulatory compliance and supporting product labelling management across multiple regions.

The role can be home or office based in various European locations.

Role Responsibilities:

  • Support Global Labelling, Regulatory (Clinical/Safety), or Medical Writing teams for labelling updates
  • Manage Company Core Datasheet (CCDS) implementation into labelling and artworks
  • Identify triggers for CCDS updates and coordinate impact assessments for technical changes
  • Apply knowledge of Safety Signal Management and its impact on labelling
  • Navigate CCDS governance processes in pharmaceutical environments
  • Understand Periodic Safety Update Reports (PSUR) and their potential impact on labelling
  • Manage the relationship between labelling and artwork processes
  • Implement regulatory processes required to update product labelling (various variation categories)
  • Prepare Addendum to Clinical Overview (Module 2.5) to support labelling variations
  • Apply regulatory requirements for labelling updates across different regions (EU, EAEU, US, APAC)
  • Manage SmPC, PIL and QRD requirements, EU linguistic reviews, and translation activities
  • Coordinate readability and PIL testing processes
  • Review and approve consumer-facing materials in accordance with approved labelling
  • Participate in promotion review committees and provide regulatory guidance for local markets
  • Provide technical and business consulting services within area of expertise
  • Complete activities within project scope, timeline, and objectives

Skills and Experience required for the role:

  • University Degree in a Scientific or Technical Discipline
  • Initial years of labelling/regulatory experience with global responsibilities
  • Regulatory Operations (Submission management) experience
  • Outstanding interpersonal and intercultural communication skills (written and verbal)
  • Critical thinking and problem-solving abilities
  • Fluent in English, written and spoken

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