Regulatory Labeling Artwork Specialist

Contract duration: 1 year with possible extension

Kelly FSP is currently on the lookout for Regulatory Artwork Management - Administrator to join the team of our client - one of the top 5 world pharma companies.

Responsibilities:

• Use of Artwork management System 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:

• Basic pharmaceutical knowledge
• Labelling experience within Regulatory Affairs
• 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, Arabic, and Russian
• Accuracy, precision and respect of timelines is mandatory