Reporting to the Exe. or Sr. Director, CMC this position will provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs for development and commercial gene therapy products. Lead submissions with minimal supervison for one or more RA CMC development and/or marketed products and provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. Works closely with subject matter experts with responsibility for assuring the regulatory CMC strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and in high quality. This position provides product regulatory CMC strategy and direction to Tech Ops, Quality, commercial and clinical teams internally and agency engagement and alliance partner interactions externally.