The overall objectives of the BIO-GRID network should be to create a robust ecosystem where bioinformatics serves as the catalyst for transformative discoveries, bridging the gap between data
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
Works in close collaboration with the external service provider and Investigators to ensure quality and quantity commitments are achieved in a timely and efficient manner.
Managing initial clinical trial application submissions in the EU according to the Clinical Trial Regulation and all changes during the life cycle of clinical trials.
Regulatory Coordinator will support the Director, Regulatory Affairs and other Senior Directors in International Markets to organize and perform required tasks for regulatory affairs in order to maintain compliance with current regulations and in-house standards.
CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, has received a Notice of Compliance (NOC) from Health Canada’s Biologics and Radiopharmaceutical Drugs Directorate (BRDD) for Dyrupeg™, its pegylated filgrastim biosimilar.