Our Client is a mission focused and innovative group that are known for developing an exciting new class of medicines to treat ultra rare disease in Children. Backed by solid investors and led by an experienced team of industry veterans, this group has already successfully produced a drug and are currently in the clinic.
The role:
This is an international regulatory strategy role. You will be responsible for defining and executing a paradigm changing regulatory pathway both in the U.S and in the UK to facilitate the treatment of Children for which every moment counts.
Reporting to the CEO, this is a full-time remote leadership role that offers a rare opportunity to join the executive team of a small, innovative company with a truly humanistic mission—transforming the approval process for a new class of ASO therapies designed to treat ultra-rare neurodegenerative conditions in children.
Experience:
20+ years in biopharma
10+ years gained in Drug Development Regulatory functions
ASO or RNA experience
Proven track record of success - CTA, BLA, IND, NDA
Solid relationship with FDA and EMA (MHRA)
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