My client, a major European pharmaceutical company, is keen to recruit a Regulatory Affairs Executive for their operation in Manchester.
Salary - £22-26,000
Job Purpose:
Maintain product licences held by the Company. Ensuring that they are kept up to date, notifying the Regulatory Authorities and making sure the process runs smoothly. Providing support and deputising for the Senior Regulatory Executive as and when required.
Profile:
The successful candidate should have hands on experience in a regulatory/licensing environment, with a good working knowledge of all the processes and legislative procedures that need to be adhered to by a pharmaceutical organisation. A science based degree would be essential as there is a requirement to gain a sound technical understanding of clinical and manufacturing aspects of company products. They must be an organised and accurate worker, able to plan ahead effectively, and work to and meet strict deadlines.
Responsibilities:
Preparation and submission of applications for renewal, variation and change of ownership to the Regulatory Authorities in a timely and accurate manner, taking into consideration commercial needs
Prepare responses to questions issued by the Regulatory Authorities
Follow up with Regulatory Authorities on submissions and regulatory issues
Request, review and submit all PSURs as required
Direct negotiations and liaisons with 3rd party companies and other departments of the company concerning submission applications
Writing, reviewing and advising on SmPCs and packaging
Keep up to date with the latest guidelines and legislation, advising colleagues on implications of any changes.
File maintenance and organisation
Maintain smooth running of the regulatory department and the licensing update processes
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