Artwork Implementation Specialist
Our client, a leading pharmaceutical company, is looking to hire an Artwork Implementation Specialist to join their team in Surrey, UK on a contract basis.
- Responsible for tracking and real-time transparency of the approval status of packaging components, in line with the EMA (European Medicines Agency) regulatory guidelines.
- Responsible for initiation of Packaging Artwork Requests (PARS), and will coordinate across business lines to assure key regulatory timelines for Artwork implementation are met
- Track the approval status of packaging artwork components the EU region - max 28 country approvals.
- Respond to document requests from legal for product litigation/defence related to labeling.
- Liaise with European Country Offices in coordinating Regulatory new or update activity for packaging artwork labeling for Client products.
- Communicate/coordinate with key stakeholder groups for documentation of labeling artwork timelines
- Liaise with Research Strategists on target dates for artwork completion on behalf of the Country Offices, and in conjunction with Manufacturing (working to SOPs/best practice guidelines).
- Raise and coordinate packaging artwork change controls in the Artwork system (ePALMS) according to agreed timelines and established procedures
- Evaluate content of labeling updates and raise issues with the EU ALIM Lead and the Regulatory Strategists as appropriate.
- Develop and maintain relationships with relevant stakeholders in WSR and PGS.
- Use pharmaceutical packaging & artwork knowledge and experience to collaborate with Manufacturings Artwork Centres to assist Country Offices in creating accurate Artwork change control instructions
- Identify appropriate artwork Country Approvers and electronically route artwork to them for approval using the ePALMS system.
- Interact and follow up with all Market Approvers as needed, and re-direct any Regulatory queries as they arise during the approval process.
- Work with minimal direct supervision. Working from home required at times.
- EU Travels if/as requested
Education and Experience:
- 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)
- Bachelors degree or equivalent in an appropriate discipline, plus related work experience (2-4 years)
- Familiar with Regulatory environment, and have an understanding of labeling regulations and controls.
- Able to interact with Clients globally distributed Stakeholders: Country offices, Manufacturing sites and Artwork Centre personnel in a professional manner.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Numhom Sudsok on +44 203 8718 093 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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