UK CW Manager European Labelin
An exciting opportunity has arisen at a leading biopharmaceutical organisation with extensive experience in discovering, developing, and manufacturing innovative human therapeutics. The opening is for a UK CW Manager European Labelling at their base in the UK. Please note that this a contract position.
- Labelling aspects to support timely product launches.
- Leading cross functional Labelling project teams.
- Creating artwork components for all of Europe.
- Creating Patient Information Leaflets (PIL) in central Europe to ensure Patients can safely and effectively use company products.
- Applying European Labelling regulations, guidelines, and industry standards, ensuring state of the art E2E Labelling processes.
- Leading specific Labelling initiatives and executing 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:
- Applying 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 launching plans e.g. health authority requirements, colour, layout, pack sizes, languages, branding.
- Developing EU package component labels according to regulations and company guidelines.
- Developing Patient leaflet content using knowledge gained from previous interactions with health authority and patients and executing it through regulatory approval.
- Overseeing 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
- amend protocol/leaflet as necessary for main stage
- review and finalise readability testing report and ensure submission ready
- Leading QRD compliance review of PI at all phases of health authority review and launch.
- Acting as Labelling contact person for internal and external audits and inspections
- Preparing responses to Labelling questions from health authorities for EU-central markets, reviewing comments, updating PI, and providing responses and updated mock ups.
- Applying continuous improvement practices and processes by anticipating problem areas, looking at current processes, and developing solutions; escalating issues appropriately.
- Proactively identifying opportunities or troubleshoot issues, utilising analytical skills to evaluate and interpret complex situations and problems using multiple sources of information with systems.
- Proposing workarounds/corrective actions on LEXA, IMR, EPIC for all European countries.
- Providing daily support on above systems and TrackWise.
- Selecting and managing vendors for readability and linguistic reviews, including preparing responses to vendor queries.
- Using project management skills to initiate and manage translations for EU-central countries, ensuring health authority timelines are met.
- Project managing timeline waivers and approving in LEXA; triaging and reviewing deviation requests for appropriateness and completeness.
- Reviewing and approving MAA EN master artwork to ensure compliance with approved mock up/text mapping.
- Negotiating and addressing questions with EMA on specimens submitted prior to launch.
- Reporting label changes to HA.
- Mentoring/training junior team members and local regulatory and operations staff on End to End Labelling processes & systems as requested by supervisor.
Skills and Requirements:
- Demonstrable project management skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Emily Oakley-Keenan at +44 2038542469 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.
£0.00 - £55 per hour
A leading medical technology company is advertising a vacancy for a Regulatory Affairs Manager - Labelling position.