Regulatory Affairs Manager - London

Regulatory Affairs Manager -London

As the Regulatory Affairs Manager you will be tasked with handling global Regulatory Affairs maintenance work on licensed products globally.

Candidates will have the following responsibilities:

* Plan, manage and execute regulatory activities on products such as submission of variations, renewals, and Marketing Authorisation Applications in further countries
* Drive submissions through National, MRP, DCP and CP (CP and National are essential for this position)
* Interface with regulatory counterparts in affiliate companies as well as internal departments to support regulatory activities on assigned products
* Plan and coordinate dossier preparation and review of submission documents
* Review of PSURs and coordination of PSUR submission
* Act as point of contact for EU Regulatory Authorities

Experience Necessary:

* Experience in global Regulatory Affairs maintenance work
* Extensive National and Centralised Procedure experience
* Degree in pharmacy/life science
* Experience working with European Regulatory Authorities
* Proven European regulatory submissions capability, in particular in post authorisation activities
* Detailed knowledge of EU regulations and guidelines, in particular on submissions post approval
* Knowledge of eCTD

This is a permanent full-time position based inLondonwith a leading global pharmaceutical company.

This position offers a salary of circa £57500 with excellent benefits.

Please contact Alan Lloyd on 02077587311 for more information on this excellent position.To find out more about Real please visit www.realstaffing.com