European Labelling Manager
CK Group is recruiting for a European Labelling Manager to join a company in the Pharmaceutical industry at their site based in Cambridge on a contract basis for 12 months and has an hourly rate of £65.
The Company: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Our client has been a biotechnology pioneer since 1980. They have grown to be one of the world's leading independent biotechnology companies, reaching millions of patients around the world. Currently they are developing a pipeline of medicines with breakaway potential.
The Location: Our client is situated about 3 km to the north of the historic and picturesque city of Cambridge. This location is easily accessible by car, train or by bus.
- Leading cross functional labeling 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 company products.
- Applying European Labeling regulations, guidelines and industry standards and be able to apply this knowledge to ensure state of of the art E2E labeling processes.
- 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 labeling 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.
- Accountable leading QRD compliance review of PI at all phases of health authority review and launch.
- Labeling contact person for internal and external audits and inspections.
- Accountable for preparing responses to labeling questions from health authorities for EU-central markets, review comments, update PI & provide responses & updated mock ups.
- Apply continuous improvement practices and processes by anticipating problem areas, looking at current processes and developing solutions; escalate issues appropriately.
- Extensive regulatory labelling experience.
- Oral and Written Communication and Presentation Skills.
- Project Management skills such that candidate can work independently to deliver expected outputs.
- Relationship Management.
- Influencing, Negotiation and Decision Making Skills.
For more information or to apply for this position, please contact Lucy Stendall on 01246 457725 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46619 in all correspondence.