Statistical Programmer12 MonthsGlobal Biopharma, Full-TimeWorking home-based (UK Only)About the Company:We are recruiting for an experienced Statistical Programmer for an initial 12 month contract on behalf...
My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Labelling Manager - EU on an initial 12 month contract to be based in their offices in Cambridge.
To be responsible for labelling aspects to support timely 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 in central Europe to ensure Patients can safely and effectively use internal products.
- Applying European Labeling regulations, guidelines and industry standards and be able to apply this knowledge to ensure state of the art E2E labelling processes.
- Apply expert labelling knowledge, industry experience and business needs to provide strategic input to stakeholders 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 company 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 for preparing responses to labelling questions from health authorities for EU-central markets, review comments, update PI & provide responses & updated mock ups
- Proactively identify opportunities or troubleshoot issues utilizing analytical skills to evaluate and interpret complex situations and problems using multiple sources of information with company systems & propose workarounds/corrective actions on LEXA, IMR and EPIC for all European countries. Provide daily support on above systems and TrackWise.
- Degree - any life sciences
If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@srg.co.uk or 01753 589673