Job Details

Job Summary:

Please call Matt Greig on +44 (0)207 801 3382 or direct on +44 (0)7918 679 405 (eves / weekends). Alternatively you can email me on Matt.Greig@AdvRegulatory.com

Requirements:

Please call one of Advanced Regulatory's principals for Regulatory Affairs, Matt Greig on +44 (0)207 801 3382 or +44 (0)7918 679 405. Alternatively you can email me on CV@AdvRegulatory.com
_________________________________________________

REGULATORY CMC Expert * BIO * Based UK or Europe ** Senior Manager / Associate Director / Director ** Lifecycle strategies WITH AN EMPHASIS on combination devices

My client is seeking an individual with CMC for proteins drug substance and drug product but with an emphasis in your experience in combination devices for protein. On offer with this role is a great mix of products, all requiring a CMC expert with knowledge of devices (Centralised procedure as they are not vials). You will have done this before, developed regulatory strategies and pressure test the device and combination components for European or International filings, although this role will offer you US experience as well.

You may be currently working with a biopharmaceutical company or for a consultancy where this is your specialist area, be qualified in EU submissions for biological products including CMC and have managed at least one major filing for a combination device in the EU. You will be able to work well with senior stakeholders in both commercial and supply chain, as well as with research and development, contract manufacturers and the regulatory global leadership team.

_________________________________________________

About Advanced Regulatory

Advanced Regulatory has been serving the regulatory affairs community since 2004. Now in our 8th year, we have placed many of the key individuals in the UK, European and Swiss RA departments - we work across borders - and have helped many individuals lever their experiences for their career benefit.

We provide a high level of service because we work with Regulatory people every day and we know our recruitment subject matter.

Keywords / Key words: CMC Regulatory, Regulatory CMC, Senior RA CMC; Reg Affairs, RA, Regulatory CMC jobs, RA CMC jobs, Regulatory Affairs CMC Jobs.