Manager, Regulatory Affairs (Gene Therapy)

Description

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.

Position details

The Manager, Regulatory Affairs, will play a hands-on, execution-focused role supporting clinical regulatory strategy for ETX-301 in neuropathic pain and contributing to ex-US efforts for ETX-101. This individual will drive day-to-day regulatory activities for clinical-stage gene therapy programs, including preparation and coordination of US and EU submissions and support for global health authority interactions.

The ideal candidate brings industry experience in cell and/or gene therapy, a strong foundation in clinical regulatory strategy (vs. purely CMC), and preferably exposure to European regulatory pathways, adult neurology, pain, and/or device or in vitro diagnostic interfaces. This is a US-based remote role (West Coast preferred but not required) reporting into the regulatory l