GSK hiring for Regulatory Specialist III- CTA/IND development delivery

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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