GSK hiring for Regulatory Specialist III-CTA/IND development delivery
Regulatory Specialist III-CTA/IND development delivery
Job description
Site Name: Bengaluru Luxor North Tower, India – Maharashtra – Worli Mumbai
Posted Date: Jul 12 2024
Job Purpose :
The Job holder works within the development delivery function has to ensure that appropriate content for specific submissions supporting R&D projects is developed and delivered to agreed timeframes and in compliance with GSK process and policy as they apply to the role.
Key Responsibilities :
· Coordination of CTA/IND submissions, to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with GSK policy and procedures
· Accountable to the functional CTA/IND Team Lead for overall work plans and to Global Regulatory Leads or Regional Representatives for definition of requirements within an agreed project.
· Accountability for agreed tasks and projects.
· Ensure independent communication, with a range of internal GSK staff, in support achievement of the assigned goals.
· Ensure compliance with GSK CTA/IND process through timely action and completion of records in internal GSK systems
Ensure quality of own work to agreed timeframes, including compliance with GSK systems and record keeping
Job-Related Experience:
2-3 years of relevant experience
Role requires a general understanding of CTA/IND submission requirements for multiple countries/ submission types and an ability to work in a matrix environment.
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