This position is reports into the Vice President of Regulatory Affairs and Medical Writing. The incumbent is responsible for providing regulatory CMC leadership and guidance to regulatory strategy and CMC teams developing cell and gene therapy products, including generation of quality dossiers to support Health Authority meetings, INDs/CTAs/IMPDs, and marketing applications in the U.S. and multiple international territories.  This role involves working closely with technical CMC teams, program teams, as well as sits on the Global Regulatory Strategy subteam.  Experience in neurology, ophthalmology and/or cardiovascular therapeutic areas and knowledge of global regulations for the development of cell therapy products is desired.

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