Senior Regulatory Affairs Officer EU

£45000 - £55000 per annum +
11 Nov 2017
16 Dec 2017
Contract Type
Full Time
A market leading pharmaceutical company is recruiting for a Senior Regulatory Affairs Officer to join their team, based in Buckinghamshire. This position would focus on the European market and report into the Deputy Head of Regulatory Affairs.

This role will give you the opportunity to plan, prepare and project manage high quality documentation for new EU licences and post approval changes affecting EU markets. You will be required to liaise with relevant departments to ensure regulatory requirements for submissions are met and provide advice on the most efficient approaches to submissions. In addition to this, proactively communicating with regulatory authorities to expedite submissions and approvals will be necessary.

You will benefit from working within a leading international speciality pharmaceutical company providing essential medicines to over 20 countries around the world. They operate principally in the UK and the Middle East and are the market leaders in several classes of medicines in both of these markets. They are currently growing their European market which has created the need for this specialist position, making your role vital to this expansion.

Key skills:

Degree in Pharmacy, Chemistry or life sciences;
Good knowledge of Regulatory European procedures and regulatory filings;
Minimum 7 years Regulatory Affairs experience which includes the preparation of modules for the regulatory dossier in eCTD format, submission of variations, renewals, new licence application submissions using regional specific procedures; and
Good knowledge of CTD dossier writing, particularly Modules 1 to 3.

The opportunity to work with this pharmaceutical organisation would provide a highly competitive salary plus benefits including private medical insurance, excellent pension scheme and much more.

If you believe you have the experience and capabilities to fulfil this Senior Regulatory Affairs Officer role then please reply immediately or call Claire on ##### ######.

Sthree UK is acting as an Employment Agency in relation to this vacancy. Advertised through Zoek 1227e86f718a43f790edf7e03d3ea73a2