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 6 Month basis to be based at their office in Tadworth.
The Role:The Regulatory Artwork Implementation Manager 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 metFollowing the initiation of the PAR process in the business system (ePALMS), the Regulatory Artwork Implementation Manager will then track the approval status of packaging artwork components the EU region - max 28 country approvals. They are also required (as necessary) to respond to document requests from legal for product litigation/defense related to labeling.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 on behalf of the Country Offices, and in conjunction with Manufacturing.* Raise and coordinate packaging artwork change controls in the Artwork system by:- Supporting Affiliates with initiation of electronic Artwork Requests, ensuring accurate entry of required data, and that all relevant regulatory documents are attached and routed for approval.- Tracking/monitoring the status of Artwork requests and artwork component approvals with the Affiliates.- Communicating with Country Offices and Manufacturing on status of Artwork requestes.* Evaluating content of labeling updates and raising issues with the EU ALIM Lead and the Regulatory Strategists as appropriate.* Develop and maintain relationships with relevant stakeholders.* Use pharmaceutical packaging and artwork knowledge and experience to collaborate with Manufacturing's Artwork Centres.* Identify appropriate artwork Country Approvers and electronically route artwork to them for approval.* EU Travels if/as requested Skills/Experience Required:Demonstrated previous experience with:* 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).
Qualifications:* 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: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.* Experience of working in a quality environment, strictly following SOP and working practices. * Familiarity with, and demonstrated use of electronic Artwork and Labeling Management Systems (eg Client ePALMS business system) or equivalent.* Excellent organisational skills* Strong, demonstrated project management experience and expertise.* In depth knowledge of manufacturing and manufacturing plant processes/requirements. * Must have capacity to make appropriate business decisions when facing uncertainty.* Must be a team player/builder.If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: firstname.lastname@example.org or +441615077288
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