Senior Regulatory Affairs Associate

15 hours ago

Bucharest, Bucureşti, Romania Parexel Full time 40,000 - 60,000 per year

We are seeking a highly organized and strategic Senior Regulatory Affairs Associate specializing in Artworks to join our team. In this pivotal role, you will work with various clients, develop and execute artwork strategies for our global product portfolio, ensuring comprehensive oversight throughout the product lifecycle.

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

Role Responsibilities:

Strategic Leadership

  • Execute and maintain artwork implementation strategies across our global portfolio
  • Serve as the main point of contact for Regulatory Affairs on all artwork matters
  • Proactively address planning requirements and CAPA (CC, Deviation, Complaint) issues
  • Develop and maintain global product portfolio plans, including change assessments
  • Establish strong connections with key stakeholders (Regulatory Affairs, Supply Chain, Technical Operations)
  • Represent the Artwork team to Regulatory Affairs and other departments as needed

Change Proposal Management

  • Track project management for artwork-related initiatives
  • Process change proposals, including reception and documentation
  • Plan and coordinate project kick-off meetings
  • Monitor timelines, follow up on approvals, and track implementation
  • Document first released batches with new artworks
  • Ensure clear communication across multiple stakeholders

Artwork Project Management

  • Create and schedule artwork projects
  • Coordinate artwork creation and approval processes
  • Track all project tasks to meet cross-functionally agreed timelines
  • Collaborate closely with internal and external stakeholders
  • Create and manage Mock-Up projects in artwork management systems
  • Ensure timely completion of tasks aligned with deliverable expectations

Skills and Experience required for the role:

  • Bachelor's Degree in a Scientific or Technical Discipline
  • 3-5 years of experience in an industry-related environment
  • In-depth understanding of pharmaceutical industry regulations, particularly in Regulatory and Supply Chain
  • Comprehensive knowledge of end-to-end Labeling & Artwork activities
  • 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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