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GSK India
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Regulatory Associate Manager, Global Labelling

Regulatory Associate Manager, Global Labelling

GSK India

7 - 12 years

9 - 14 Lacs

bengaluru

Posted:12 hours ago| Platform:

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Skills Required

procurement matrix pharmacy focus pharma manager technology healthcare oncology life sciences recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Position Summary
This is an exciting opportunity to play a key role in supporting global regulatory labelling activities. You will collaborate with cross-functional teams to ensure timely and compliant labelling submissions that align with regulatory requirements. We are looking for a detail-oriented and proactive individual who is passionate about making a meaningful impact on global healthcare. Join us to grow your career while contributing to GSK s mission of uniting science, technology, and talent to get ahead of disease together. Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Maintain/Update the Company Core Datasheet / Global Datasheet (CCDS/GDS) in conjunction with functional experts.
Maintain/Update the EU PI (CP/MRP/DCP), International Product Information (IPI), Vaccine WHO and PAHO PI and Medical Device product labels. Ensure compliance with global PI and submit country labelling deviations if any.
Manage the Product Information for products in conjunction with a third party.
Coordinate the readability testing of the EU Package Leaflet when applicable.
Lead the discussion at Labelling Review Team (LRT) around the proposed wording for the CCDS/GDS and centrally managed PIs (when applicable) and seek agreement with all stakeholders involved.
Author and coordinate the supportive packages for submission to the Global Labelling Committee (GLC). Author GLC meeting minutes (if applicable).
Support the Local Operating Companies (LOC):
- in the implementation of Global PI text into country PI.
- in authoring and coordinating responses to labelling questions from regulatory agencies.
- in evaluating LOC submission delay request and facilitating its approval if required.
Take accountability for relevant labelling sections of the periodic aggregate reports like PBRER, ACO, Addendum Reports, DSUR, etc.
Member of the Regulatory Matrix Team (RMT) and the Safety Review Team (SRT) as appropriate.
May represent Global Labelling in Product Investigation Review Committee (PIRC) and internal audits.
May represent GSK Global Labelling in
- inspections or meetings with regulatory authorities.
- external events (conferences/seminars, etc.).
- Train/coach others in future, as required

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals: - Masters degree in Life Sciences, Pharmacy, Dental or Medical.

>7 years relevant experience (in labelling or regulatory affairs) .
Understanding of the pharmaceutical industry, drug development environment and regulatory processes.

Preferred Qualification
If you have the following characteristics, it would be a plus:

Experience in an international regulatory environment.
Knowledge of digital tools and platforms, such as Veeva Vault.
Familiarity with regulatory lifecycle management processes.
Ability to work collaboratively in a matrix environment.
Proactive problem-solving skills and ability to adapt to changing priorities.

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Regulatory Associate Manager, Global Labelling