Regulatory Artwork Implementation Manager

3 weeks ago


Tadworth, United Kingdom SRG Full time
SRG

are currently looking for Regulatory Artwork Implementation Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team on an initial 12 Month basis to be based at their offices in Kent (hybrid).

The Role:nResponsibility for tracking and real-time transparency of the approval status of packaging components, in line with the European Medicines Agency regulatory guidelines.nResponsible for initiation of Packaging Artwork Requests and coordinating across business lines to assure key regulatory timelines for Artwork implementation are met.nTracking the approval status of packaging artwork components the EU region.

Key Responsibilities:nLiaise with European Country Offices in coordinating Regulatory new or update activity for packaging artwork labeling for Client products.nCommunicate/co-ordinate with key stakeholder groups for documentation of labeling artwork timelines.nLiaise with Research Strategists on target dates for artwork completion.nRaise and coordinate packaging artwork change controls in the Artwork system.nEvaluate content of labeling updates and raise issues as appropriate.nDevelop and maintain relationships with relevant stakeholders.nUse pharmaceutical packaging and artwork knowledge/experience to collaborate with Manufacturing Artwork Centres.nWork with minimal direct supervision.

Skills/Experience Required:nExtensive experience of working with regulated document management tools supporting; storage, retrieval, lifecycle management and tracking of labeling artwork for packaging components in a business enterprise system (e.g. ePALMS or similar).nBachelor’s degree or equivalent in an appropriate discipline, plus related work experience (2-4 years).nMust be familiar with Regulatory environment and have an understanding of labeling regulations and controls.nMust be able to interact with Client’s globally distributed Stakeholders in a professional manner.nPC skills including spreadsheet, database management are required.

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