Artwork Implementation Manager (Regulatory)

Artwork Implementation Manager

Role type: Temporary

Duration: 12 months

Location: Sandwich, Kent or Tadworth, Surrey

I am currently working with a Global Pharmaceutical Organization who have a key contract opportunity within their Regulatory team. They are seeking an Artwork Implementation Manager to support for the next 12 months. The client requires the successful candidate to have extensive experience of working with regulated document management tools supporting; storage, retrieval, lifecycle management and tracking of labelling artwork for packaging components in a business enterprise system (e.g. ePALMS or similar). Ideal applicants will have up to 4 weeks' notice and be based in either their Kent or Surrey offices. This role is office-based but will offer some flexibility (up to 2 days) for home-working.

Role overview:

The Contractor is responsible for tracking and real-time transparency of the approval status of packaging components, in line with the EMA (European Medicines Agency) regulatory guidelines. This role is responsible for initiation of Packaging Artwork Requests (PARS), and will coordinate across business lines to assure key regulatory timelines for Artwork implementation are me

Following the initiation of the PAR process in the business system (ePALMS), this assignment will also require the contractor to track the approval status of packaging artwork components the EU region. They are also required (as necessary) to respond to document requests from legal for product litigation/defense related to labelling.

Main Responsibilities may include:

Liaise with European Country Offices in coordinating Regulatory new or update activity for packaging artwork labelling for Client products.
Communicate/co-ordinate with key stakeholder groups for documentation of labelling 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 labelling 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 Manufacturing's Artwork Centres to assist Country Offices in creating accurate Artwork change control instructions - so called 'Editors Copies' (EC).
Identify appropriate artwork Country Approvers and electronically route artwork to them for approval using the ePALMS system.

Skills/experience required:

Bachelor's degree or equivalent in an appropriate discipline, plus related work experience (2-4 years).
Must be familiar with Regulatory environment and understand labelling regulations and controls.
Must be able to interact with Client's globally distributed Stakeholders. Country offices, Manufacturing sites and Artwork Centre personnel in a professional manner
PC skills including spreadsheet, database management are required.
Possess strong interpersonal, writing and verbal communication skills.
Experience of working in a quality environment, strictly following SOP and working practices, and focusing on accuracy and a 'right first time' approach to their work.
Demonstrated use of electronic Artwork and Labelling Management Systems (e.g. Client ePALMS business system) or similar.
Excellent organizational & project management skills, with ability to manage several product artwork changes simultaneously, with varying stakeholders.
In depth knowledge of manufacturing and manufacturing Plant processes/requirements. Knowledge of Pharmaceuticals manufacturing preferred.

To Apply

Please follow the link or if you would like to discuss this position in more detail, please contact Theo Charles for further information

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy