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Regulatory specialist- CTA/IND development delivery

Bangalore, India

Site Name: Bengaluru Luxor North Tower
Posted Date: Dec 8 2022

Are you looking for a regulatory affairs role that will enhance your documentation knowledge and allow you to help shape systems strategy? If so, this Regulatory Affairs Operations role could be an exciting opportunity to explore.

As a Regulatory Affairs Operations Staff, you will work with the Governance, Compliance, and the Systems team within Global Labelling to ensure that labelling updates in Online Product Authorisation and Lifecycle (OPAL) are monitored and managed in compliance with GSK procedures.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

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• Coordinate data collection and reporting process for compliance with timelines for delivery of labelling updates with partners at global, regional, and local levels

• Manage data collection, report dissemination, and follow-up for flagged events within an agreed schedule

• Support the building of a tool and process for setting up baseline data, resource tracking, and forecasting

• Work with Global Labelling teams to improve visibility and access to performance data

• Assist the management team with reports to address performance queries (related to source data) and work with functional group to identify root causes of deviations, or ingredients of success

• Support the system administration of the labelling systems, including training of global and local users, in accordance with GSK policies and procedures

• Work closely with IT Business System Owners to coordinate solutions delivery and support, such as User Acceptance Testing

• Support development and maintenance of labelling websites, Team sites, and other communication channels

• Participate in other projects and activities that support other labelling functions, such as contributing to the implementation of changes to processes within Global Regulatory Affairs (GRA)

• Escalate risks and variances from plan or target when appropriate

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree
  • Experience with Labelling systems, standard operating procedures, and legislative requirements
  • Experience with entry, tracking and registration data management systems
  • Regulatory document management experience, including experience with Documentum databases and MS team sites
Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Master's degree
  • Excellent verbal and written communications skills
  • Ability to work carefully under time constraints and prioritize accordingly
  • Adaptable to fast-paced environments with changing circumstances, direction, and strategy
  • Exposure to work within a regulated environment, ideally in drug development
Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - 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's 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're 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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Client-provided location(s): Bengaluru, Karnataka, India
Job ID: glaxo-356029-en-us
Employment Type: Other