• Manages the overall process of regulatory submission preparation and review, including Investigational New Drug applications (INDs), Biologics License Application (BLAs), New Drug Application (NDAs), investigational device exemption (IDEs), Annual Reports, and other regulatory documents.
• Develop and advance the organizations policy and procedures for regulatory affairs and compliance to establish a compliant culture.
• Ensures compliance with the applicable domestic and international regulations and guidelines including Good Manufacturing Practice (cGMP), current Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and providing support for TRI’s internal Quality Assurance Program/Quality Systems.
• Manage the development of the Standard Operating Procedures (SOPs) that support the Regulatory Affairs operations.
• Provide guidance for resource and development planning.
• Supervises Regulatory Affairs managers, and, where no manager is assigned, Regulatory staff directly.
• Interacts with study sponsors, project managers, clinical research staff and Food and Drug Administration (FDA) to ensure timely receipt and submission of information required for FDA submissions.
• Participates in the preparation and review of technical proposals.

• Ph.D., Pharm D., or M.S. or equivalent related experience in science (biology, chemistry, biochemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, toxicology), regulatory affairs, or another applicable field.
• Strong scientific, regulatory affairs, clinical research, and/or project management background.
• Solid working knowledge of drug development process and FDA regulatory requirements.
• Solid working knowledge of ex US regulatory requirements preferred.
• Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.
• Strong management and leadership skills; experience in leading submissions teams.
• Direct experience interacting with government regulatory authorities preferred.
• Superior organizational skills and customer service abilities.
• Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well.
• Proficient in Microsoft office; experience with SharePoint a plus.

Job Snapshot