Job Ref: 213449548

Date: 2021-03-29 14:03:11

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We are currently looking to recruit for a Regulatory Affairs Officer for our client who are a global pharmaceutical company for a 12 month contract based in Milton Keynes.

The main purpose of the role is to help ensure the necessary regulatory approvals are 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.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

Regulatory Affairs Duties

To ensure that the regulatory requirements of Intervet International 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 colleagues within Intervet/MSD Animal Health as well as the Licensing Authorities.

To ensure that ensure that the ‘UK Regulatory Affairs Information’ and databases (i.e. Alchemy) are correct and up to date

To ensure that product data included in the MSD Animal Health UK Ltd Intranet and in external references such as NOAH Data Sheet Compendium 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.

To assist the Commercial Operations Dept by checking printed promotional material for compliance with the product’s Marketing Authorisation, upon request.

To keep the Product Managers fully informed of any significant internal or external regulatory changes which may affect the marketing or use of their products.

To have an active and proactive role within the RA team and externally to investigate and identify solutions to daily problems & activities which the RA team have to manage: packaging, authorities, commercial group, etc.

To liaise with the Irish RA Manager in the management of the regulatory compliance of products with joint UK/IE packaging.

Knowledge, Skill And Experience Required

* 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.

* Ability to assemble and present data.

* IT skills, particularly Microsoft Office (Word) and database skills and ability to learn new software as required.

* Ability to work methodically and accurately yet swiftly and to deadlines.

* Good attention to detail.

* Ability to remain calm under pressure.

* Sound interpersonal skills for effective liaison with a wide range of people and organisations.

* Wide-ranging and sound verbal and written communication skills.

* Proactive, an initiative taker, who is able to work unsupervised.

* Ability to prioritise and self-organise.

* Interest in other aspects of the animal health industry

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