Regulatory Affairs AD EU

Regulatory Affairs EU Lead - Contract job, 12 months

Your new company

This biotechnology company specializes in developing treatments for rare diseases and is looking for an experienced Regulatory Affairs Professional to join them on a 12-month contract as EU Regulatory Lead. This contract job has flexible working arrangements and has scope for extension.

Your new role

As EU Regulatory Lead, you will take responsibility for a molecule being developed for 3 related indications and act as the EU Lead with regards to planning, preparation, and submission of clinical trials as well as other Health Authority interactions in Europe.
A key element of this contract job as EU Regulatory Lead is to assist with selected planning, document development, and meeting execution activities in preparation for Health Authority or EMA meetings/interactions and develop and coordinate content for EU regulatory submissions, Clinical trials, Orphan Drug designation, and Paediatric Investigation Plans.

What you'll need to succeed

In order to be considered for this 12-month contract job, you must have knowledge and experience of EU Regulatory requirements and procedures and be able to develop, implement, and communicate the Regulatory Strategy. It is essential you are experienced with EU Guidance and leading Regulatory procedures, especially clinical trials (working with CROs) and submission of Type II variations for new indications.

What you'll get in return

• Competitive rates of pay (PAYE or Umbrella)

• Flexible working options (remote working)

• Scope for extension

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.