Associate Director Regulatory Affairs CoDx / IVD ** M25/M3/M4 ** Lead EU registrations of CoDx’s for a medium-sized Biotech

Reference: CA10588B

Expiry Date: 28-06-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

United Kingdom

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Job Description

This role is based on the M3 and commutable (2 days a week) from Reading to Slough, and west Middlesex, down to west Surrey, south Berks and Hampshire.

The company operate a part hybrid work policy and you will be attending site 2 days a week. There is limited travel in this role!

About My Client & The Role

My client is one of the most respectable names in R&D Bio-/Pharma, have around 35000 employees world-wide, with annual sales of around 25B USD, and invest a healthy 25% of T/O on R&D. This company rarely recruits because people just do not leave the organization that often! This is a newly created role, a standalone position in Europe for an Associate Director of Regulatory IVD & CoDx’s to support primarily their neurology and inflammation clinical development pipeline.

This is a superb opportunity for an individual who wants to work across multiple NMEs, to support with Vendors and with the Global team, the EU regulatory pathway for the IVD and CoDx devices, with your stakeholders being therapy regulatory, precision meds, clinical and, externally, with the Vendors and also the Assessment Bodies. This role offers variety!

The role reports to an Executive Director level person, who is based in the USA, so it is important for this role you have the experience and skills to directly engage with key stakeholders and project teams with a level of independence.

The role is to lead the development of IVDs for their therapy areas which include metabolism, inflammation, oncology and neurology, not necessarily in this order, for use sometimes as standalone IVDs as well as companion diagnostics (agnostic, safety, biomarkers, etc).

The regulatory team for the EU are based in the same office, and they have various hubs for international, which you will indirectly support.

The Package

My client is offering Associate Director level benefits, car allowance and bonus.

Your Experience

You will have around 5 years or more in CoDx or IVD regulatory affairs, including leading Vendors or direct CE Marking registration, support for CoDx / Drug development (from the device perspective) and based on a strong scientific background in terms of your early career or qualifications.


To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Christian, for this role by email to or if you would like more information on the role, on +44(0) 207 801 3382. I will support you throughout the interview and on-boarding experience.

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