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Manager European Labelling

  • Job reference: 927839
  • Location: Cambridge, Cambridgeshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences
  • Date posted: 23/09/2019

Hello all. I am currently seeking a Manager European Labelling for an initial 12-month contract with our client in the Cambridgeshire. Please contact me at Andreia.Terron@orioneng.com for more details

Manager European Labelling

Description: The Labelling Process Management Manager, reporting into the Director Labelling Process Management, will be accountable for: Labelling aspects to support timely client 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.

Primarily responsible for Manager European Labelling activities, which may include any/all of the following:

  • 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 the clients' products
  • 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)
  • 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 the clients' 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
  • 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
  • Apply continuous improvement practices and processes by anticipating problem areas, looking at current processes and developing solutions; escalate issues appropriately
  • Proactively identify opportunities or troubleshoot issues utilizing analytical skills to evaluate and interpret complex situations and problems using multiple sources of information with client systems & propose workarounds/corrective actions on LEXA, IMR, EPIC for all European countries. Provide daily support on above systems and TrackWise
  • 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
  • Reportability of label changes to HA
  • Mentoring/training junior team members and local regulatory, operations staff on End to End Labelling processes & systems as requested by supervisor.

Basic Qualifications:

  • Project Management skills such that candidate can work independently to deliver expected outputs
  • Relationship Management
  • Influencing, Negotiation and Decision Making Skills
  • Extends capabilities by working closely with senior staff/experts within and outside the internal organization
  • Oral and Written Communication and Presentation Skills

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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