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Regulatory Affairs Project Manager

Regulatory Affairs Project Manager

The Company
A rapidly expanding global pharmaceutical organisation are seeking a Regulatory Affairs Project Manager to join their UK team.

Job Summary
In this role you will assist the Regulatory Affairs Manager and the UK Regulatory Affairs team in providing regulatory services to customers and clients. You will take responsibiliy for ensuring that registered marketing authorizations and licences undergoing registration are compliant with current regulations and that they meet the company needs. You will obtain and maintain Marketing Authorisation applications for Europe and the rest of the world.

Duties and Responsibilities

*Act as regulatory Project leader on assigned stages of certain projects by coordinating the regulatory workflow, providing regulatory support to the team

*Compile and complete regulatory deliverables (variation applications, marketing authorisation applications, etc) for assigned projects

*Supervise regulatory affairs executives within designated project phases

Qualifications and Experience

* A graduate degree, preferably in a scientific discipline
*Experience of EU regulatory procedures required. Dealings with European agencies an advantage
* European regulatory experience specifically with MRP/DCP procedures, and a proven track record in running national and MRP submissions within European markets for MAA's and experience of running variation procedures
* Ability to prioritize and plan projects and work
* Excellent leadership skills


Key Words: Regulatory Affairs, Global, Regulatory Affairs Project Manager, London, South East, Relocatable.

We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk