Regulatory Artwork Implementation Manager

4 weeks ago

Tadworth Surrey, 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:

Responsibility for tracking and real-time transparency of the approval status of packaging components, in line with the European Medicines Agency regulatory guidelines.

Responsible for initiation of Packaging Artwork Requests and coordinating across business lines to assure key regulatory timelines for Artwork implementation are met.

Tracking the approval status of packaging artwork components the EU region.

Key Responsibilities:

Liaise with European Country Offices in coordinating Regulatory new or update activity for packaging artwork labeling for Client products.

Communicate/co-ordinate with key stakeholder groups for documentation of labeling artwork timelines.

Liaise with Research Strategists on target dates for artwork completion.

Raise and coordinate packaging artwork change controls in the Artwork system.

Evaluate content of labeling updates and raise issues as appropriate.

Develop and maintain relationships with relevant stakeholders.

Use pharmaceutical packaging and artwork knowledge/experience to collaborate with Manufacturing Artwork Centres.

Work with minimal direct supervision.

Skills/Experience Required:

Extensive 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).

Bachelor’s degree or equivalent in an appropriate discipline, plus related work experience (2-4 years).

Must be familiar with Regulatory environment and have an understanding of labeling regulations and controls.

Must be able to interact with Client’s globally distributed Stakeholders in a professional manner.

PC skills including spreadsheet, database management are required.

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