Senior Regulatory Affairs Associate

2 days ago

Bucharest, Bucureşti, Romania Parexel Full time

We are seeking an experienced
Senior Regulatory Affairs Associate Labelling
to develop and execute artwork strategies for our global product portfolio. In this critical role, you will ensure comprehensive oversight throughout the product lifecycle while serving as the primary liaison between Regulatory Affairs and various stakeholders.

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

Role Responsibilities

  • Prepare Label updates for EU, US and ROW markets
  • Coordinate readability testing
  • Coordinate and manage translations for EU markets
  • Management of linguistic review
  • Manage GRA label Compliances (e.g., QC process)
  • Develop, manage and track label governance for EU, US and ROW markets
  • Prepare & support Label negotiations for EU, US and ROW markets
  • Manage/coordinate global labeling change impact assessment for dependent markets
  • Manage and track governance for label content creation for EU, US and ROW markets
  • Develop, manage and track governance for company position (e.g. CCDS) and foundational markets
  • Manage advertising and promotion materials
  • Prepare and management artwork
  • Labeling summaries for periodic reports

Skills And Experience Required For The Role

  • Bachelor's Degree in a Scientific or Technical Discipline
  • In-depth understanding of pharmaceutical industry regulations, particularly in Regulatory Affairs
  • Capable of reviewing technical documents and influencing colleagues across functions.
  • Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management.
  • Experience in Flu campaigns and pandemic products.
  • Strong project management capabilities
  • Client-focused approach with results orientation
  • Excellent teamwork and collaboration abilities
  • Critical thinking and problem-solving aptitude
  • Fluent in English written and spoken

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