Regulatory Specialist - Labelling Coordination - GSK

Job description

Site Name: Egypt - Cairo
Posted Date: Jun 15 2020

Job Purpose:

Provide support to GRA Labelling staff to ensure the timely management and communication of global, country and regional Product Information/labelling documentation.

Effective coordination, communication and maintenance of labelling documents and data in regulatory systems in accordance with defined standards and processes.

Key Responsibilities

• Efficient coordination and communication of labelling documentation such as Global Product Information (PI), International PI, Country Labelling Differences, Responses to Agency Labelling Questions, EU PI (including translations) and US PI
• Providing support to GRA Labelling staff to ensure the quality and consistency of labelling document content including editing Global/regional/country PI, generation of Country Labelling Differences and periodic reports, and management of labelling artwork in accordance with relevant processes, templates and standards
• Storage of labelling documentation in regulatory systems including communication of approved Global and regional/country PI
• Efficient communication with GSK staff (including Global Regulatory Affairs, Global safety and medical and Local Operating Companies) to collate, compile and perform quality checks of labelling documents
• Management of GRA Labelling data in regulatory systems such as: PRION, GRACE, OSCAR, IMMS, eCTD Backbone, OPAL, HARMONY. 
• Supporting GRA-labelling processes and systems in accordance with GSK policies and procedures
• Supporting other labelling functions and participation in other projects and activities as needed, such as contributing to the implementation of changes to processes within GRA Labelling.

Knowledge/ Education / Previous Experience Required:

• University Bachelors' degree
• Area of Specialization: Life Sciences
• A Master's degree will be a plus
• 3 to 7 years of experience in pharmaceutical industry, life sciences research or regulatory.
• Fluent spoken and written French is a must (French school graduate)
• High Attention to detail and time management skills.
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Ability to think flexibly in order to meet shifting priorities and timelines.
• Good working experience in Regulatory document management (particularly experience of working with and amending Product Information/Labelling Documents)
• Good working experience within documentum databases and MS team sites
• Familiarity with entry, tracking and registration data management systems
• Working knowledge of product information/labelling documentation

Contact information:
You may apply for this position online by selecting the Apply now button.

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