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GlaxoSmithKline is one of the leading global healthcare companies, driven by innovation and scientific developments. Our mission is to improve the quality of life, enabling people to do more, feel better and live longer. Global Regulatory Platform and Delivery (GRPD) in GlaxoSmithKline is a regulatory affairs function which brings together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, license maintenance and lifecycle management dossiers and regulatory data management, labeling outputs. GRPD provides regulatory support across the product lifecycle for pharmaceutical products (clinical development to market maturity).
The Global Regulatory Platform and Delivery team are creating new roles in the CMC Variations Poznan team. The purpose for the role will be leading or participating in global CMC Variation projects, timely maintenance of post approval CMC changes for Finished Product and Active Pharmaceutical Ingredients, providing expertise and support to Local Operating Companies with respect to post approval changes and responses to Regulatory Agency questions about Products.
CMC Regulatory Specialist
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above. Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.
Please apply using the online application system.
Thank you for your interest in this role.