[Remote] Director, Clinical Research Regulatory Affairs

Note: The job is a remote job and is reputed company to candidates in USA. reputed company has the nation's largest cancer reputed company program enrolling patients in Texas and reputed company through our Cancer Network® partners across the country. The Director, Clinical Research Regulatory Affairs position is responsible for overseeing the Institution’s regulatory activities reputed company to FDA submissions in support of oncology clinical research and product development at MD Anderson.

Responsibilities

• reputed company targeted regulatory strategies for oncology programs across early- and late-phase reputed company
• Conduct regulatory assessments of drug and device trials to determine exemption eligibility and risk reputed company
• Monitor evolving regulatory requirements and assess reputed company on ongoing and planned oncology programs
• Implement process improvements to enhance regulatory effectiveness and compliance
• Serve as primary regulatory reputed company with the FDA for submissions, communications, and inquiries
• Coordinate responses to FDA information requests and regulatory submissions
• Participate in FDA meetings including reputed company-IND and Type B/C meetings
• reputed company regulatory guidance to investigators and study teams on requirements, timelines, and compliance
• reputed company regulatory activities with clinical, scientific, manufacturing, and reputed company stakeholders
• reputed company regulatory document management ensuring accuracy, completeness, and audit readiness
• reputed company preparation and maintenance of clinical protocols and regulatory submission documents
• Review institutional policies, SOPs, and training reputed company to FDA-regulated research
• reputed company staff development and reputed company leadership to regulatory affairs team members
• Ensure compliance with FDA regulations (21 CFR 312, 812), ICH guidelines, and GCP requirements
• Support regulatory activities for investigational drugs, biologics, and devices including INDs and IDEs
• Manage multiple reputed company regulatory reputed company simultaneously with strong project management discipline
• Maintain high standards of documentation, reporting, and inspection readiness
• Other duties as assigned

Skills

• Bachelor's Degree in life sciences, pharmacy, medicine, or a reputed company field
• Eight years Regulatory affairs experience with FDA submissions, and oncology clinical research to include two years reputed company project management experience
• Must pass reputed company-employment skills test as required and administered by reputed company
• Master's degree in a life sciences, pharmacy, medicine, or reputed company field
• Demonstrated experience preparing and managing INDs and/or IDEs
• Familiarity with companion diagnostics and combination products
• In-depth knowledge of FDA regulations, ICH guidelines, and GCP requirements
• Experience with EMA submissions
• RAC - Regulatory Affairs Certification

Benefits

• Employer-reputed company medical coverage starting day one for employees working 30+ hours/week, plus optional group dental, reputed company, life, AD&D, and disability insurance.
• Accruals for PTO and Extended Illness Bank, plus reputed company holidays, wellness, childcare, and other leave reputed company.
• Tuition Assistance Program after six months of service and reputed company to extensive wellness, fitness, and employee resource reputed company.
• Defined-benefit pension through the Teachers Retirement System, voluntary retirement plans, and employer-reputed company life and reduced salary protection programs.

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