The Regulatory Specialist, Country Labelling provides support to GRA Labelling staff, Regulatory Matrix Teams, and Labeling Review Teams to ensure the timely update, management and communication of quality US Product Information (PI)/labelling and supporting documentation. The Regulatory Specialist, Country Labelling ensures effective coordination, communication and maintenance of US labelling documents and data in regulatory systems in accordance with defined standards and processes.

Key Responsibilities:

• Authors (and/or assists authors with) quality and regulatory acceptable new/revised prescribing information for products marketed in the US.
• Author and/or compile market-specific supporting documentation for labelling submissions in accordance with regulatory authority requirements and GSK process and standards.
• Produces all required versions of prescribing information documents for submission purposes and ensures all submission requirements are met for these documents.
• Ensure accurate version control of multiple labeling submissions and components.
• Develops FDA-compliant XML labeling documents for submission in accordance with GSK or FDA timelines.
• Works with internal Drug Listing experts to coordinate Drug Listing submissions via XML labeling.
• Complete quality and consistency checks of labelling document content.
• Efficiently coordinate and manage labelling documentation and data in regulatory systems.
• Provides summaries of Labeling updates as needed for NDA or BLA Annual Reports.
• Provide advice regarding regulatory authority labelling requirements and GSK labelling process and standards to GRA US roles and via Regulatory Matrix Teams.
• Effectively communicate with GSK staff (including GRA, Global Safety and Medical, and Labeling Review Team) to author, compile and deliver quality labelling documents.
• Support other regulatory functions and participate in other projects and activities as needed, such as assisting in the design and implementation of changes to labelling processes and evaluation of new agency labelling requirements.
• Subject Matter Expert in labelling content and process for complex US labelling requirements:
  • provides coaching, mentoring and knowledge sharing within GSK Labelling group o completes quality checks for colleagues’ outputs o effectively manages interactions with Senior Stakeholders
  • takes accountability for the management of US labelling deliverables, including delivery of high quality outputs to timelines
  • May represent GSK externally

Why You?

Basic Requirements:

• Bachelors degree in life sciences or equivalent years of experience performing a regulatory function
• One or more years’ experience in regulatory affairs

Preferred Requirements:

• Attention to detail, significant experience of document and database management, excellent organization and time management skills to handle multiple projects for different customers.
• Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner.
• Broad understanding of the pharmaceutical industry, drug development environment, development and established product lifecycle maintenance and regulatory processes.
• Knowledge and understanding of product labelling (e.g., through direct exposure to the management of labelling documents/submissions/data; including label authoring).

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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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