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Regulatory Specialist - Submission Coordinator
Location:
Bengaluru
Description:
About the job Site Name: Bengaluru Luxor North Tower Key Responsibilities : Accountable to the GRL and Global Regulatory staff for the delivery of Marketing Application, pre-approval/investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices May be responsible for leadership of relevant submission team for product regulatory authority submission or maintenance activities associated with an approved product (including product renewals, site registrations/renewals/variations, label harmonization, periodic benefit risk evaluation reports (PBRER) submissions etc) May be required to provide guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets Job Related Experience : Awareness of the pharmaceutical industry, drug development environment, and RD processes and objectives. Awareness of Regulatory Affairs responsibilities from pre-IND through Phases I-IV Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment. Ability to think flexibly in order to meet constantly shifting priorities and timelines. Ability to interpret regulations Other Job-Related Skills: Good written and verbal communication skills and ability to present information in a clear and concise manner Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines. Ability to work flexibility in large teams Please use the below link for job application and quicker response. https://lifelancer.com/jobs/view/26f8294d83630c1e668e59f77d8f01dd
Company:
Lifelancer
Posted:
May 17 on Manatal ATS
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More About this Listing: Regulatory Specialist - Submission Coordinator
Regulatory Specialist - Submission Coordinator is a Jobs Regulatory Affairs Specialist Job at Lifelancer located in India. Find other listings like Regulatory Specialist - Submission Coordinator by searching Oodle for Jobs Regulatory Affairs Specialist Jobs.
Regulatory Specialist - Submission Coordinator is a Jobs Regulatory Affairs Specialist Job at Lifelancer located in India. Find other listings like Regulatory Specialist - Submission Coordinator by searching Oodle for Jobs Regulatory Affairs Specialist Jobs.