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Job Description Summary: Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! This position is responsible for providing generic drug product labeling for pharmaceutical products based on reference listed drug labeling and health authority issued guidance in line with Sandoz internal policy and procedure. To support in labeling preparation and/or review for new submission, life cycle management through change controls, launch activities, and for other business partnership deals as required. Roles and Responsibilities: Major Responsibilities but not limited to: 1. Prepare labeling for submission by gathering all required source documents from all function/partners, internal/external stakeholders across geolocations. 2. Prepare and/or review submission package consisting of mock-up labels, draft prescribing information, side-by-side comparison, and structured product labeling (SPL) in both pregnancy and lactation labeling rule (PLLR) and non-PLLR formats. 3. Coordinate with other stakeholders (such as artwork studio, CMC, site technical representative) to create, review, and approve the labeling, such as package inserts, medication guide, patient information leaflet, container and carton labels for new submission and life cycle submission. 4. Capable to work independently within labeling team and across other functions. 5. Responsible for the drug product registrations via structured product labeling (SPL), maintenance of product drug listings and delisting, labeling posting to DailyMed database. 6. Responsible to assess the impact of new changes and/or proposals and drive implementation through creation and/or review of change controls for completeness and accuracy in line with Sandoz internal procedure and practice. 7. Participate in department and project meeting during county local business hours. Maintain centralized labeling tracker for all responsible products in tracking apps, Microsoft excel and SharePoint etc., 8. Responsible for providing timely and valid guidance to labeling questions for both internal and external partners. Responsible for meeting all deliverables timeline and commitments with all internal and external partners. Desired Characteristics Basic Qualification and Experience: Bachelor degree and minimum with 6 years of experience in pharmaceuticals industry experience, with 3 of those years in regulatory affairs labeling. Master degree a plus! Must have strong regulatory labeling knowledge and process-oriented mind set to solve problems for pharmaceutical products. Must be able to operate computer efficiently and well acquainted with Microsoft Office Suite (Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft OneNote, Microsoft Outlook, Microsoft OneDrive, Microsoft Teams). Show more Show less
