Regulatory Affairs Artwork Specialist - RX

The Regulatory Management Center is a new regional organization to handle most of Local Operating Companies activities led by senior regional regulatory staff, where they will handle tactical Life Cycle Management processes (CMC Variations and Labeling Changes) in the region. The Center will be embedded EMEA region, and it will work in close collaboration with the respective Local Operating Companies and regional and global departments.

Responsibilities:

• Use of ePackMat to initiate artwork for new labelling or changes to current labelling into
• production and/or generation of mock-up needed for regulatory submissions
• Complete review of the artwork (using electronic tool, where possible) and co-ordinate the final
• approval of the artwork with Local Operating Companies driven by the agreed deadlines.
• Entering data and using tools to monitor metrics for tracking of implementation of packaging
• material
• Liaise with Local Operating Companies Regulatory Affairs, quality, Graphic Services, logistics/supply chain & production plants internal/external to interpret current stock/orders to best anticipate ex-works date (available for delivery (AFD)) to meet both Health Authorities timelines and minimize current stock /component write off costs
• Performing and/or co-ordination of Quality Check (QC) of local Product Information
• Communication with local stakeholders of the Local Operating Companies in scope during the review process

Requirements:

• Previous experience in Regulatory Affairs Junior would be an asset
• Experience of working in a virtual team and/or global organization would be an asset
• Experience in working with limited supervision and able to make independent decisions is of
• advantage
• Cultural sensitivity and ability to work and thrive in a multi-cultural environment
• Experience with computer systems usage (MS office, excel)
• Proficient level of English, Ukrainian and Russian Language
• Great attention to details and sense of responsibility

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