GSK
Grunwaldzka, Poznań, Poland
Site Name: Poznan Grunwaldzka Posted Date: Oct 23 2024 Regulatory Specialist, Renewals What we are doing? Global Regulatory Centres (GRC) in GSK are regulatory affairs functions which bring together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, licence maintenance and lifecycle management dossiers, and regulatory information management. The Global Regulatory Centres provide regulatory support across the product lifecycle for pharmaceutical, biopharm and vaccines products (clinical development to market maturity). Renewals CMC Team (Chemistry, Manufacturing, and Controls) is part of GRC and plays a crucial role in ensuring that Pharma and Vaccines products are safe, effective, and of high quality for patient use. Team is responsible for authoring, compiling, and checking regulatory submissions related to drug manufacturing and quality control. While the science is our...