Regulatory Affairs Director — Translational Research Leader

Houston Methodist; Houston (TX); On-site; USD 180,000 - 260,000; Full time

Job summary

Houston Methodist seeks a Director of Regulatory Affairs to guide regulatory strategy for HMRI's pre-clinical and clinical research, ensuring compliance with FDA and other authorities and aligning with product development timelines. The role leads the department, manages staff, budgets, and policies, and collaborates with translational research teams to prepare IND/IDE submissions and regulatory reporting.

Experience in IND/IDE, GMP, GLP, and leadership in academic medical centers is preferred;

Qualifications

• Advanced degree in scientific or related field.
• Eight years of Regulatory Affairs experience in FDA-regulated industry (devices, diagnostics, or pharma).
• Experience with IND/IDE submissions and cross-functional teams.

Responsibilities

• Directs regulatory affairs staff and aligns with strategic goals.
• Oversees submissions to Health Authorities and regulatory reporting.
• Ensures training and compliance with GMP/GLP/GCP standards.
• Leads cross-functional teams on product development programs.

Education

Advanced degree (MS, PharmD, MD)

Job description

Houston Methodist seeks a Director of Regulatory Affairs to guide regulatory strategy for HMRI's pre-clinical and clinical research, ensuring compliance with FDA and other authorities and aligning with product development timelines. The role leads the department, manages staff, budgets, and policies, and collaborates with translational research teams to prepare IND/IDE submissions and regulatory reporting.

Experience in IND/IDE, GMP, GLP, and leadership in academic medical centers is preferred;