Senior Regulatory Affairs Associate - Labelling (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 R0000036999 类别 Consulting关于这个职位
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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