Job Ref: 213458174

Date: 2021-03-30 15:38:09

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PE Global is currently recruiting for a Regulatory Affairs Officer for a leading multi-national Biotech client based in Milton Keynes.

THE ROLE:
To help achieve the objective of the Department which is that client have the necessary regulatory approvals in place, and the necessary regulatory information disseminated to enable their commercial activities to operate as efficiently as possible by dealing with general and technical aspects of regulatory activity (including compliance) relating to both new and current authorisations, including applications, renewals and variations as well as ATC applications.

KEY RESPONSIBILITIES:
• To ensure that the regulatory requirements are carried out for the UK and liaise packaging related issues with Ireland.
• To ensure that national MAs are kept up to date and appropriate.
• To ensure ARTIS approvals are done so that packaging and labelling of products comply with regulations laid down by the competent Authorities and within the licensed parameters.
• To maintain awareness of aspects dealt with by the Regulatory Affairs Manager and other Senior Regulatory Affairs Officers in order to be able to respond to queries from colleaguesas well as the Licensing Authorities.
• To ensure that ensure that the ‘UK Regulatory Affairs Information’ and databases are correct and up to date
• To ensure that product data included in client's Intranet and in external references are in line with that currently approved by UK Regulatory Authority.
• To ensure compliance of UK licensed products for both UK and international use by assisting other departments such as UK QA with regulatory help or information as necessary.

REQUIREMENTS:
• Background in a biological science to A-level or equivalent.
• Experience in regulatory affairs, ideally in a veterinary company.
• Knowledge of UK and EU Regulatory procedures.
• Ability to assess quality of technical data in relation to regulatory requirements.
• IT skills, particularly Microsoft Office (Word) and database skills and ability to learn new software as required.
• Desired:
• Knowledge of other European languages, particularly Dutch and German
• Experience in other aspects e.g. QC, production or development.

Interested candidates should submit an updated CV.
Please click the link below to apply, call Amparo on (phone number removed) or alternatively send an up to date CV amparo@peglobal.net

Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert

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