Director, Regulatory Operations

As Director, Regulatory Compliance Operations, you will oversee our regulatory approval, regulatory submission, and policies and procedures processes. This role is responsible for ensuring communications and submissions to regulatory agencies are in compliance with applicable requirements for all lines of business. 

• Contributes to the annual Plan risk assessment, collaborating with the various Compliance teams, to assist the enterprise in identifying areas with potential compliance issues.  
• Oversee the Regulatory Compliance Operations unit and their management of regulatory and material submissions and the Policy and Procedure Program. 
• Prepare and update materials for compliance committees including the Compliance Committee and Audit and Compliance Committee of the Board of Directors.
• Serve as the regulatory expert to ensure that marketing practices are consistent with regulatory guidelines. 
• Serve as the liaison...

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

This position reports to the Head of Regulatory Affairs and is responsible for operational aspects of global regulatory submissions, ensuring that submissions are high quality and submitted on a timely basis. This role is also responsible for archiving and tracking regulatory submissions and health authority correspondence. Emphasis will be on strategic planning, management, and execution of all aspects of Regulatory Operations. Additional key accountabilities include working with Regulatory Affairs, Medical Writing, Biometrics, Clinical,...