Regulatory Packaging and Artwork Manager
This role is responsible for initiation of Packaging Artwork Requests (PARS). The contractor for this role will coordinate across business lines to assure key regulatory timelines for Artwork implementation are met Following the initiation of the PAR process in the business system.
- 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 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, by performing the following activities:
- Support Affiliates with initiation of electronic Artwork Requests (PARS), ensure accurate entry of required data, and that all relevant regulatory documents are attached and routed for approval.
- Using ePALMS track/monitor the status of PARs and artwork component approvals with the Affiliates.
- In a timely manner, communicate with Country Offices and Manufacturing on status of PARs to ensure agreed regulatory timelines are met.
- 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 Manufacturing's Artwork Centres to assist Country Offices in creating accurate Artwork change control instructions
Skills and Requirements
- 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:
- Country offices, Manufacturing sites and Artwork Centre personnel in a professional manner.
- PC skills including spreadsheet, database management are required.
- Diplomatic with strong interpersonal, writing and verbal communication skills required.
- 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.
- Excellent organizational skills. Must be able to handle a number of product artwork changes at the same time, with differing stakeholder groups.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.