Global Regulatory Affairs Apprenticeship

GSK India

1 - 2 years

13 - 16 Lacs

Bengaluru

Posted:2 days ago| Platform:

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Skills Required

Procurement Usage Process improvement Focus Manager Technology Oncology HR Regulatory affairs Recruitment Investment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Accountable to the GRL and Global Regulatory 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 relevant submission team for product regulatory authority submission or maintenance activities associated with an approved product (including product renewals, site registrations / renewals / variations , label harmonisation, periodic benefit risk evaluation reports (PBRER) submissions etc)
May be required to perform scenario planning when multiple regulatory strategies are being considered and propose as necessary delivery strategies to achieve accelerated timelines.
May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities
May be the primary contact for the GRL, maintaining the overall RMT workplan (including relevant regulatory milestones according to the phase of development)
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
May be required to process improvement initiatives

Skills

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