Regulatory Specialist

Role Overview: As a Regulatory Global Labeling Operations Specialist, you will play a crucial role in authoring and updating labeling documents, ensuring compliance with Health Authority regulations, and maintaining submission quality. Key Responsibilities: - Oversee EU labels, including EU linguistic quality control (QC) coordination and support. - Coordinate labeling workflow activities and provide support for labeling change controls. - Manage artwork, including designing, reviewing, and updating packaging components. - Responsible for generating and maintaining the Structured Product Labeling (SPL) for all products. - Collaborate with regulatory and product teams to ensure accurate product labeling information. - Create, validate, and manage SPL documents. - Ensure compliance with FDA requirements for electronic submissions of labeling content. - Monitor changes in SPL standards and FDA requirements and implement necessary updates. - Coordinate with other departments to resolve any issues related to SPL content or submissions. - Manage timelines to ensure timely submission of SPL documents. - Maintain up-to-date knowledge of industry trends and advancements in the field of SP. Qualifications Required: - Work experience: 4 to 8 years. - Must have skills: Global Labelling, USPI Labelling, SPL, Artwork, Labelling documents. Note: No additional details about the company were provided in the job description.,