GSK (GlaxoSmithKline) is a leading global biopharmaceutical company with a mission to unite science, technology, and talent to get ahead of disease together. By fostering a culture of innovation and collaboration, GSK aims to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns. At GSK, people can thrive and make a difference in the world.

Job Overview

Position: Regulatory Associate Manager – Global Labelling
Location: Bengaluru Luxor North Tower, Bengaluru, India
Department: Regulatory Affairs (Global Labelling)
Education Requirements: Bachelor’s or Master’s degree in Life Sciences, Pharmacology, or equivalent
Experience Required: Over 7 years of relevant experience in the pharmaceutical industry or regulatory affairs

Job Purpose

As a Regulatory Associate Manager – Global Labelling at GSK, you will provide expert advice and support to labelling stakeholders concerning global and local Product Information (PI) processes. Your primary responsibility will be to ensure the timely maintenance of global and local labelling documents, including information for healthcare professionals and patients, and data in regulatory systems. Your role will be critical in ensuring compliance with defined standards and processes across the organization.

Key Responsibilities

As a Regulatory Associate Manager, you will be entrusted with the following responsibilities:

Global Datasheet and Product Information Maintenance

• Maintain the Global Datasheet (GDS) in collaboration with functional experts.
• Oversee the maintenance of EU PI (CP/MRP/DCP), International Product Information (IPI), Vx WHO, PAHO PI, and Medical Device product labels.
• Ensure compliance with global PI and manage any country-specific labelling differences.

Product Information Management

• Manage the PI for products in coordination with third-party partners.
• Coordinate the readability testing of the EU Package Leaflet when required.
• Lead discussions at the Labelling Review Team (LRT) regarding proposed wording for the GDS and centrally managed PIs.

Submission and Documentation

• Author and coordinate the supportive packages for submission to the Global Labelling Committee (GLC).
• Write GLC meeting minutes if applicable.
• Support Local Operating Companies (LOC) in implementing Global PI text into country PI, and in authoring and coordinating responses to labelling questions from regulatory agencies.

Process Improvement and Compliance

• Demonstrate expertise in GSK Global Labelling processes.
• Effectively plan, prioritize, communicate, and deliver quality labelling documents according to timelines and submission requirements.
• Participate in projects and activities to implement changes to labelling processes, new regulations, and guidelines.
• Identify areas for improvement and efficiency in existing labelling processes.

Reporting and Collaboration

• Take responsibility for relevant sections of periodic aggregate reports, such as PBRER, ACO, Addendum Reports, DSUR, etc.
• Be an active member of the Regulatory Matrix Team (RMT) and the Safety Review Team (SRT).
• Represent Global Labelling in Product Investigation Review Committee (PIRC) and internal audits.
• May represent GSK Global Labelling in inspections, meetings with regulatory authorities, and external events like conferences or seminars.

Training and Development

• Train and coach others as needed, sharing your expertise in global labelling processes and regulatory compliance.

Educational Requirements

To qualify for this role, you must hold a Bachelor’s or Master’s degree in Life Sciences, Pharmacology, or an equivalent field. This educational background is essential for understanding the scientific content of labelling documents and interacting confidently with highly educated staff, customers, and partners in a complex technical environment.

Experience Requirements

• A minimum of 7 years of relevant experience in the pharmaceutical industry or regulatory affairs is required.
• A deep understanding of the pharmaceutical industry, drug development environment, and regulatory processes is crucial.
• Preferred experience in labelling or regulatory affairs will be an advantage.

Why GSK?

GSK is committed to creating an environment where employees can thrive and make meaningful contributions to society. By joining GSK, you will be part of a global organization dedicated to improving the health of billions of people around the world. GSK offers a dynamic work environment, opportunities for professional growth, and the chance to work with some of the brightest minds in the industry.

How to Apply

If you are passionate about regulatory affairs and labelling, and you meet the qualifications and experience requirements, we encourage you to apply for this exciting opportunity. Click here to apply and become a part of GSK’s mission to unite science, technology, and talent to get ahead of disease together.

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This job description is designed to provide a detailed overview of the role, its responsibilities, and the qualifications required. For more information about GSK and its mission, please visit the GSK Wikipedia page.

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