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Regulatory Labelling Manager - Cambridge - 12 month freelance project
ARM Life Sciences are currently partnered with a leading Biopharmaceutical business based in Cambridge and we supporting them in their search for a European Labelling Manager to join them on a freelance contract basis for a 12 month period.
Main responsibilities for the roles are as follows-
• Labelling aspects to support product launches. The Manager achieves this by understanding the EU regional business goals and how to achieve those goal by creating and sustaining the most competitive product labels within European regulations and guidelines.
• Leading cross functional labelling project teams and ability to execute error free product labels in 49 countries in Europe.
• The creation of artwork components for all of Europe to enable timely launch of products.
• The creation for Patient Information Leaflets (PIL) in central Europe to ensure Patients can safely and effectively use.
• Applying European Labelling regulations, guidelines and industry standards and be able to apply this knowledge to ensure state of the art E2E labelling processes.
• Leading specific labelling initiatives and execute deliverables by working with cross functional teams and leaders (includes continuous improvement projects to support the E2E labelling processes)
Principal responsibilities include, but are not restricted to:
• Apply expert labelling knowledge, industry experience and business needs to provide strategic input to stakeholders (Reg Affairs, Regional Ops, Artwork, Commercial) for the creation and execution of all labelling packaging components and launch plans e.g. health authority requirements, colour, layout, pack sizes, languages, branding.
• Develop EU package component labels according to regulations and company guidelines
• Develop Patient leaflet content using knowledge gained from previous interactions with health authority and patients and execute it through regulatory approval to ensure safe and effective use of products.
• Accountable for successful Readability Testing: establish and execute process to successful results, (Revise EU label, patient leaflet, packaging components, instructions for use (collectively referred to as PI), prepare protocol and share with vendor, request patient leaflet mock-up, attend pilot stage testing and amend protocol/leaflet as necessary for main stage. Review and finalise readability testing report and ensure submission ready.
• Labelling contact person for internal and external audits and inspections
• Accountable for preparing responses to labelling questions from health authorities for EU-central markets, review comments, update PI & provide responses & updated mock ups
• Select and manage vendors for readability and linguistic reviews, including preparing responses to vendor queries
• Using project management skills initiate and manage translations for EU-central countries ensuring health authority timelines are met.
• Project manage timeline waivers and approve in LEXA. Triage and review deviation requests for appropriateness and completeness.
• Review and approve MAA EN master artwork to ensure compliance with approved mock up/text mapping
• Negotiate and address questions with EMA on specimens submitted prior to launch.
• Mentoring/training junior team members and local regulatory, operations staff on End to End Labelling processes & systems as requested by supervisor.
If you are interested in this project please contact Vik Patel on 02392 458031 or email me on firstname.lastname@example.org
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