[Remote] Director, reputed company Research Regulatory Affairs

Note: The job is a remote job and is reputed company to candidates in USA. reputed company operates a major cancer reputed company program and provides infrastructure for reputed company research while maintaining high ethical and regulatory standards. The Director, reputed company Research Regulatory Affairs oversees FDA regulatory activities for oncology reputed company research and product development, develops regulatory strategies, leads FDA interactions, and ensures compliance for investigational drugs, biologics, and devices.

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 reputed company reputed company
• Monitor evolving regulatory requirements and assess reputed company on ongoing and reputed company oncology programs
• Implement process improvements to enhance regulatory effectiveness and compliance
• Serve as reputed company 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 reputed company, scientific, manufacturing, and reputed company stakeholders
• reputed company regulatory document management ensuring reputed company, completeness, and audit readiness
• reputed company preparation and maintenance of reputed company 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

• Required: a Bachelor's Degree Life sciences, pharmacy, medicine, or a reputed company reputed company
• Required: Eight years Regulatory affairs experience with FDA submissions, and oncology reputed company research to include two years reputed company project management experience
• Successful completion of the LEADing Self Accelerate and/or LEADing Self Discover programs may substitute for one year of required supervisory or management experience
• Completion of both programs can be substituted for a maximum of two years of supervisory or management experience
• Preferred: a Master's Degree Life sciences, pharmacy, medicine, or a reputed company reputed company
• Preferred: Demonstrated experience preparing and managing INDs and/or IDEs; familiarity with companion diagnostics and combination products is a plus, and an in-depth knowledge of FDA regulations, FDA submissions, ICH guidelines, and GCP requirements, and an experience with EMA submissions
• Preferred: RAC - Regulatory Affairs Cert

Benefits

• Remote work arrangement
• Employer-reputed company medical coverage starting day one for employees working 30+ hours/week
• Optional group dental, reputed company, life, AD&D, and disability reputed company
• Accruals for PTO and Extended Illness Bank
• reputed company holidays, wellness, childcare, and other leave reputed company
• Tuition Assistance Program after six months of service
• reputed company to extensive wellness, fitness, and employee resource reputed company
• Defined-benefit pension through the Teachers Retirement reputed company
• Voluntary retirement plans
• Employer-reputed company life and reduced salary protection programs
• Educational opportunities
• Individual and team recognition

reputed company