Director Regulatory Affairs

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). 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.

Exempt

• Advanced degree (MS, PharmD, MD) in scientific or related field

• Eight years of Regulatory Affairs experience within an FDA regulated industry, preferably devices, diagnostics, or pharmaceuticals and/or within an academic medical center setting that routinely requires investigational or marketing submissions to FDA or similar Health Authorities
• Experience in reviewing and successful submission of applications to Health Authority including Investigational Drug, Device (IND/IDE) compassionate use, pre-submission requests, market applications
• Prior experience representing Regulatory Affairs on cross-functional teams is desirable;
  Must be capable of effectively leading teams in preparation of submissions. Previous managerial or leadership or lead positions

• RAC-DRUG - Regulatory Affairs Certifications Pharmaceuticals (RAPS) - Regulatory Affairs Professionals

• RAC-DEVICE - Regulatory Affairs Certifications Medical Devices (RAPS)

• Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through ongoing skills, competency assessments, and performance evaluations
• Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially about activities impacting patient or employee safety or security
• Demonstrates the ability to interact with others in a way that gives them confidence in one's intentions and those of the organization
• Ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans; modifying one's own behavior to accommodate tasks, situations and individuals involved
• Demonstrates leadership qualities and critical thinking through self-direction initiative and effective interpersonal skills and oral/written communication skills
• Ability to identify and understand issues, problems and opportunities, comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints and probable consequences
• Extensive knowledge of regulatory and accreditation agency requirements that impact department; stays abreast of industry changes
• Demonstrates highly effective communication skills—strong written communications and…