Title: Regulatory Affairs Strategy - Director
Type: Permanent Role
Notes: No Corp to Corp
· Participate in design of US, EU and Canada regulatory strategies for the development of gene therapy products for rare diseases.
· Support preparation and submissions (including but not limited to pre-IND, IND/CTA, BLA/MAA and PIPs) of high-quality regulatory dossiers in the US and EU according to set timelines; this will require, strong regulatory knowledge and experience, cross-functional interactions, excellent project management and writing skills, and a good understanding of the underlying science
· Coordinate with the nonclinical, clinical and CMC teams' submissions
· BA/BS degree in life sciences. MS/PhD preferred
· 8-10 years of regulatory pharmaceutical product development experience – preferably in biotechnology, ideally in gene therapy/ATMP CNS applications; regulatory strategy and regulatory science writing
· ICH, FDA, EMA and WHO regulations/guidelines
Next Steps : Send me a quick email if you are passively or actively looking for another opportunity.Love to speak with you.
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