Interim Regulatory Director

I am currently working exclusively with a small CRO in the US, specialising in Paediatrics.
They are seeking an Interim Regulatory Director based in Europe as soon as possible to support them for a duration of 6 months. This opportunity is offering a full FTE and fully remote working. My Client is expanding in the EU but does not have any permanent regulatory staff hired yet, whilst they are in the process of finding a permanent Regulatory Director they urgently need a freelancer to support them in their current projects.

Responsibilities:

• Regulatory Strategy covering all phases of clinical development from pre/early clinical to phase III
• Writing/preparing regulatory submissions (including PIPS, INDs, IMPDs, MAAs, BLAs, ODDs)
• Interfacing with Regulatory Authorities (EMA)
• European Regulatory Lead
• Be involved in the strategy of setting up Regulatory and other areas framework/structure

Requirements:

• Extensive strategic Regulatory experience working with all stages of development
• Experience with Regulatory documentation and track record of achieving submissions for different stages of pre-clinical and clinical development (including PIPS, INDs, IMPDs, MAAs, BLAs, ODDs)
• EU Market experience
• Understands Regulatory requirements and strategy of how to take a product through entire clinical development
• Paediatric Drug Development experience
• Experience working with CROs
• Orphan Drug/Rare disease experience
• Immediately available

My Client is looking for a Regulatory Director Contractor to start immediately. Interviews to take place this week.

I specialise in recruiting Regulatory Affairs professionals throughout Europe, if you would like to speak to me regarding the above position then please call me today on +44 (0)1293 77 66 44 for a confidential discussion.

Alternatively you can reach me on Linked In or e-mail me on JASmith@barringtonjames.com.

If you are interested in discussing any of my other vacancies, or simply want to be made aware of opportunities as they arise then please contact me or have a look at available jobs on the Barrington James Website.

I look forward to hearing from you soon!

Jasmine Smith

Contract Consultant ~ Regulatory Affairs

+ 44 (0)1293 77 66 44