Regulatory Specialist IQVIA India

About IQVIA India

Job Description

Project role : Regulatory Specialist Work experiences : 4 to 8 years. Work location : Delhi/ Mumbai Mode of work : Hybrid Must have skills : Global Labelling, USPI Labelling, SPL, Artwork, Labelling documents Job 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. Job Responsibility: 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. Collaborates with regulatory and product teams to ensure accurate product labeling information. Create, validate, and manage SPL documents. Ensures compliance with FDA requirements for electronic submissions of labeling content. Monitors changes in SPL standards and FDA requirements and implements necessary updates. Coordinates with other departments to resolve any issues related to SPL content or submissions. Manages timelines to ensure timely submission of SPL documents. Maintains up-to-date knowledge of industry trends and advancements in the field of SP,