Regulatory Officer

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    Alannah Fisher

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  • Published:

    6 months ago

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Regulatory Affairs Officer
Up to £35K per annum plus benefits

My client, a pharmaceutical company based in Runcorn, is looking to recruit a Regulatory Affairs Officer to join their Technical department.

Reporting in to the Head of Technical, you will be responsible for ensuring the appropriate licensing and legal compliance for their product range in order to ensure products are safe and meet customers an regulatory expectations.

Key responsibilities of the Regulatory Affairs Officer are:

* Provide advice and support on technical and regulatory issues to both internal and external issues
* Support customers with product registrations and export documentation ins various markets
* Compile technical dossiers and statements for customers product registrations
* Submit regulatory documents such as licence variations to the Regulatory authorities
* Liaise closely with customers and the sales team to progress projects
* Act as deputy Pharmacovigilance QP
* Ensure raw materials comply with relevant legislation
* Perform PQRS for licensed products
* Work closely with NPD and quality departments to ensure all products are fully compliant

The ideal candidate for the Regulatory Affairs Officer will have:

* A degree (or equivalent), preferably in life sciences or in a pharmaceutically related subject
* Relevant experience of working in the regulatory arena and a sound knowledge of European procedures is essential
* Experience in UK/IE and EU applications and submissions
* An exceptional eye for detail required

If you are an experienced Regulatory Affairs Officer looking for a new challenge please apply now!

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