Senior Regulatory Affairs Associate - Artwork (home or office based)
Bucharest, Bucureşti, Romania Additional Locations: Croatia, Remote; Croatia, Zagreb; Czech Republic, Prague; Czech Republic, Remote; Hungary, Budapest; Hungary, Remote; Poland, Remote; Poland, Warsaw; Romania, Remote; Serbia, Belgrade; Serbia, Remote 职位编号 R0000035628 类别 Consulting关于这个职位
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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