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The Regulatory Affairs team ensures compliance, efficient registration, and license to operate of pharmaceutical products, vaccines in Ukraine, supporting company operations and quality standards. The Registration Associate manages regulatory processes for product registration, renewals, and variations, while ensuring compliance with regulations and GSK standards. The role involves collaboration with internal teams and regulatory institutions to support product registration and support maintenance of the Quality Management System (QMS).
Job Responsibility:
Ensure support in preparation, update and completion of registration dossier according to local requirements in order to obtain new registration, renewals and variations for pharmaceutical products, vaccines
Proactively escalate in case of risks, issues
To conduct verification checking of ANDs, PILs in accordance with registration materials prepared for submission to the Regulatory Authority, or/ and in accordance with approved reg. documents
Ensure support in coordination of registration questions as well as labeling and GMP compliance
Upon receiving requests/comments from local regulatory authorities, ensure proper archiving of them
Maintain appropriate level of archiving and usage of documents in compliance with Company’s and local requirements. To archive registration dossiers and communications with RA databases
Support the payment process for registration procedures in accordance with the company's requirements and timelines. Monitor the status of payments for registration procedures. Prepare and archive payment documents in compliance with company requirements. Regularly update the payment registry