RA Manager, Global Labeling

Role Overview: You will be responsible for performing tasks assigned as per applicable procedures, including CDS and core English SmPC/PIL/Label preparation and maintenance. Additionally, you will be involved in signal detection and evaluation, translations, submission strategy for EU, maintenance of internal databases, collaboration with Regulatory Associates, and support to country organization. Key Responsibilities: - Perform tasks assigned as per applicable procedures (e.g., GOPs, SOPs, WIs) - Prepare and maintain CDS and core English SmPC/PIL/Label - Monitor HA websites for external signal detection - Evaluate signals for their impact on patient safety - Maintain core SmPC/PIL/Label based on changes - Define submission strategy for EU and interact with HAs - Update internal databases/RIMS - Support compliance/performance reporting - Represent global labelling team in internal (safety) boards Qualification Required: - Post Graduate degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) or Healthcare Professional - 10 years of experience in global labelling or other regulatory affairs functions - Good understanding of drug safety information - Ability to collaborate effectively with cross-functional teams - Sound understanding of medical and scientific terminologies Additional Details: Sandoz is a leader in the Generic and Biosimilar medicines sector, providing over 900 million patient treatments across 100+ countries. The company is focused on shaping the future by investing in new development capabilities, production sites, acquisitions, and partnerships. Sandoz offers an open, collaborative culture with opportunities for personal growth and impactful careers in a diverse and supportive environment.,