Sr. Manager, Submission Delivery Excellence

4 days ago


Bengaluru, India ScaleneWorks Full time

position holder(s) will be accountable for managing integrated teams of Regulatory Submission Delivery professionals in end-to-end processes to meet GSK's Investigational Drug Developments and Regulatory compliance obligations. The position holder will act as an SME between GRO and GCO on operational topics related to Investigational Drug Development processes. This position which involves influencing stakeholders at all levels within GRA and driving harmonization and business change activities across a broad customer base, in addition to ensuring on time and quality delivery of submissions for R&D development projects. This role provides Regulatory leadership to link the business mission, strategy, and required processes to fulfil GSK s obligations with Health Authorities related to Regulatory submissions and will be responsible for driving continuous improvement and innovation of GSK Regulatory systems and processes. The Sr. Manager will work collaboratively with stakeholders to agree on priorities and implementation timelines for Regulatory submissions globally to maximize the business value from a GSK perspective while meeting Regulatory Authority requirements. This role will include leadership within and across enterprise matrix teams including GRA (both central and at the Local Operating Company level), GRO, and contributing departments as needed to meet submission delivery expectations. The Sr. Manager will provide functional leadership for a team of direct reports in multiple locations globally.



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