Regulatory Associate Manager - Global Labelling
Regulatory Associate Manager - Global Labelling
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Job Description
Maintain the Global Datasheet (GDS) in conjunction with functional experts.
Maintain the EU PI (CP/MRP/DCP) International Product Information (IPI) Vx WHO and PAHO PI and Medical Device product labels. Ensure compliance with global PI and submit country labelling difference if any.
Manage the PI 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 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.
Demonstrate expertise in GSK Global Labelling processes.
Remote Work :
No
Employment Type
Full Time
