Director, Regulatory Affairs

About the role

At Houston Methodist, the Director Regulatory Affairs position is responsible for providing regulatory guidance regarding pre-clinical and clinical research as well as product development support in compliance with applicable regulations and standards for Houston Methodist Research Institute (HMRI).

Responsibilities

This position assists research teams with understanding and development of clinical investigational plans, expectations for data needed to support product development programs or regulatory reporting or application.

The Director position responsibilities include overseeing the activities of the department staff, ensuring quality, productivity, functional excellence and efficiency to accomplish strategic and operational objectives.

In addition, this position is accountable for employee engagement, adequate staffing levels, budget development and compliance, staffing decisions such as hiring and terminating employment, coaching and counseling employees on work-related performance, and developing and implementing policies and procedures to ensure a safe and effective work environment.

This position also ensures training, monitoring and operations initiatives are implemented which secure compliance with ethical and legal business practices and accreditation/regulatory/government regulations.