Regulatory Specialist Msr Coordination

Year    Bengaluru, Karnataka, India

Job Description


Site Name: Bengaluru Luxor North Tower
Posted Date: Jan 11 2023
With minimal input from manager, executes agreed dossier strategy related to MSR packages Liaise with MSR suppliers & customers (GMS, External Supply QA, LOCs) to obtain documentation in a timely manner. With minimal input from manager, manages multiple project assignments supporting Variations, Product Expansion dossiers, Renewals and regional projects simultaneously; MSR packages/documents will range in complexity With minimal input from manager, completes data assessment to ensure MSR package is fit for purpose, identifies risks associated with submission data and MSR packages. Communicates with line manager to identify issues that have business impact. May have responsibilities for reviewing work of peers and may identify improvement opportunities for Regulatory processes, policies and systems. Developing an understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical and vaccines products, Understands internal/external Regulatory environment. Actively builds an organizational network. Communicates across GSK, with minimal input from manager regarding projects and new requirements impacting MSR deliverables GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We\xe2\x80\x99re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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Job Detail

  • Job Id
    JD2995978
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Bengaluru, Karnataka, India
  • Education
    Not mentioned
  • Experience
    Year