I am currently partnered with a Biotech in Portugal who are developing drugs for Neurodegenerative diseases. My Client is seeking a Regulatory Expert to work with them on a remote basis for at least 6 months. The Regulatory Expert will support the Regulatory Affairs Lead as a Consultant.
- Providing Regulatory and Scientific Advice regarding IND/IMPD
- Liaising with the R&D Department
- Organising/attending Regulatory Authority meetings
- Responsible for Orphan Drug Designations
- Authoring/Reviewing Regulatory Submissions such as CTA
- Compilation of Investigator Brochure
Suitable candidates will have:
- Pre-Clinical/Non-Clinical experience – IND/IMPD, IBs, Briefing Books, Scientific Advice
- Experience in Regulatory Authority Meetings – FDA and EMA
- Therapy area - Rare Disease experience is a must – Neurodegenerative diseases
- Experience with Orphan Drugs
- Pharmaceutical background
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!
Contract Consultant ~ Regulatory Affairs
+ 44 (0)1293 77 66 44