Global labelling
6 days ago
Job Title: Regulatory Labelling SpecialistExperience Required: 8–10 years of global regulatory labelling experienceJob SummaryWe are seeking an experienced Regulatory Labelling professional to join our global team. The ideal candidate will have a strong background in global labeling strategies, particularly within U.S. and EU regulatory frameworks. This role requires a deep understanding of Core Data Sheets (CDS) and the end-to-end process of label development, updates, and compliance across markets.
Required Skills & Qualifications8–10 years of core experience in global regulatory labelling. Strong knowledge of U.S. FDA and EU EMA labelling regulations and guidelines. In-depth understanding of CDS development and maintenance.
Proven ability to interpret regulatory guidance and apply it effectively. Excellent communication skills (written and verbal). Strong interpersonal skills; ability to influence and collaborate across a matrixed, multicultural organization.
Track record of sound decision-making and problem-solving under pressure. Experience working in cross-functional, global teams with a strong sense of ownership and accountability. Comfortable interacting with stakeholders at all levels, including senior leadership.
Key ResponsibilitiesInterpret and apply global and local regulatory guidelines related to product labeling, including pre-approval and post-approval phases. Analyze the impact of proposed label changes across sections and recommend integrated updates to maintain consistency and compliance. Maintain a strong understanding of Core Data Sheets (CDS), United
States Package Inserts (USPI), Summary of Product Characteristics (SmPC), and related patient labeling documents across centralized, MRP, and DCP procedures in the EU.Ensure timely and accurate updates to global labeling documents in accordance with evolving regulatory requirements. Lead discussions with cross-functional teams, providing labeling strategy guidance aligned with overall product objectives. Collaborate closely with stakeholders (regulatory, medical, safety, commercial, etc.) to align on labeling content and strategy.
Represent labeling function in global teams and interface with senior management as needed. Proactively identify labeling risks and propose mitigation strategies. Own project timelines and deliverables, handling multiple tasks and priorities effectively.
Must-Have KnowledgeCore Data Sheets (CDS)United States Package Inserts (USPI)Summary of Product Characteristics (SmPC) for products registered via Centralized, MRP, or DCP routesAssociated Patient Labeling Documents
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