England, Regulatory Affairs Associate Director (Rare Disease Biotech) RA_DN_11558-MZ
My client is a research stage US biopharma with global operations. they are in a truly exciting position as they look towards registering their first product in the US and EU. This opportunity would be to support the filing of a new MAA, the companies first. and to be the contact point with other EU affiliates, providing support prior to launch of this rare disease product.
You will be a seasoned regulatory affairs professional who has worked in multiple organisations on pre-approval projects (IMPD, CTA, CTD) within drug development (CHMP approval, centralised procedure) sphere of regulatory affairs. Should you have worked on new indications programs for established products then this too is valid experience.
A resilient individual you will get the opportunity to work with cross functional teams to deliver on a critical project for a company which has a vision for the future which is ambitious and bold. If this is of interest to see a full job description and salary information, please get in touch without delay.
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