鈥� Coordinating and handling the compilation and submission of all regulatory submissions, including but not limited to INDs, CTA's, MAAs, NDAs, BLAs, sNDA, amendments, annual reports and other maintainance submission to worldwide Health Authorities.
鈥� Responsible for reviewing regulatory submissions for accuracy, consistency and completeness with regulatory and internal requirements as appropriate.
鈥� Being a part of Global Submission Publishing team, I have worked on several key major and maintenance submissions by collaborating with Submisssion Management team and various line functions.
鈥� Possess knowledge about life cycle of each submission related activity and lot of insight...
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