Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products. Sandoz
To work as per cGMP and ensure its compliance as per current guideline and SOPs. Responsible to take training before execution of allotted work & maintaining the training file.
To coordinate and author documents needed for regulatory submissions, ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members.
The incumbent will support the implementation of internal standards, provide study-level CDISC guidance, conduct quality reviews of deliverables from CRO partners, and ensure clinical data packages meet inspection-readiness criteria for global health authorities.