European Labelling Manager

Key People


Job ID :

15321


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,--Cambridge,Cambridge,


Key Skills :

Regulatory Affairs, Labelling, MHRA, EMEA, Artwork, PILs, Mock-Up, MAAs


Salary :

£45.00 - £52.00 per hour


Date Posted :

23 Sep, 2019



Company Name :

Key People


Location1 :

Cambridge




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

My client, a large pharmaceutical company in the Cambridge area, is looking for a European Labelling Manager on a 12 month contract paying up £52.

The Labeling Process Managemnt Manager, reporting into the Director Labeling Process Management, will be accountable for:

* Labeling aspects to support timely company 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 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 product launch.
* 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 at company.
* Leading specific labeling 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 labeling 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 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 leading QRD compliance review of PI at all phases of health authority review and launch.
* Labeling contact person for internal and external audits
* 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.
* 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, 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

If the above may be of interest, please apply and get in touch with Ross Wilson at rwilson@keypeople.co.uk





Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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