Director, Regulatory Affairs & Translational Research

Houstonmethodistcareers; Houston (TX); On-site; USD 180,000 - 240,000; Full time

Job summary

Houston Methodist seeks a Director of Regulatory Affairs to guide regulatory strategy for pre-clinical and clinical research and support product development at HMRI. You will lead submissions to Health Authorities and advise research teams on data needs for regulatory reporting.

The role oversees department staff, ensures compliance with applicable regulations, and drives quality, staffing, budgeting, training and policy implementation to sustain a compliant and productive environment.

Qualifications

• Eight years of Regulatory Affairs experience in FDA-regulated industry or academic medical center setting.
• Experience in reviewing and submission of applications to Health Authorities including IND/IDE.
• Ability to lead cross-functional teams and manage submissions.

Responsibilities

• Directs regulatory affairs operations and strategy to move projects from lab to regulated environments.
• Oversees staff development, staffing, budgeting and policy implementation.
• Guides training, compliance and ethical/regulatory practices across the department.

Skills

Regulatory leadership

Regulatory submissions

Cross-functional collaboration

Regulatory knowledge

Education

Advanced degree

Tools

IND/IDE submissions

Job description

Houston Methodist seeks a Director of Regulatory Affairs to guide regulatory strategy for pre-clinical and clinical research and support product development at HMRI. You will lead submissions to Health Authorities and advise research teams on data needs for regulatory reporting.

The role oversees department staff, ensures compliance with applicable regulations, and drives quality, staffing, budgeting, training and policy implementation to sustain a compliant and productive environment.