Manages and/or supervises a Team of Regulatory Managers, Regulatory Specialists, Regulatory Operations Associates, and Human Subjects Protection Specialists
Assists in managing the overall process of regulatory submission preparation and review, including Investigational New Drug applications (INDs), Annual Reports to INDs, Investigator's Brochures (IBs) and other regulatory documents
Ensures high quality work products are consistently delivered on time to the client, the FDA, and other Regulatory Health Authorities.
Supports the Department Director in ensuring 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
Supports the development of the Standard Operating Procedures (SOPs) that support the Regulatory Affairs operations
Interacts with study sponsors, project managers, clinical research staff and Food and Drug Administration (FDA)/other Regulatory Health Authorities to ensure timely receipt and submission of information required for regulatory submissions
Coordinates professional development as needed to support regulatory document preparation, regulatory intelligence, and regulatory strategy, and to stay current with applicable therapeutic areas of clients
Assists the Department Director with staff hiring, training and recruitment strategies, and staff performance evaluations
Develops and implements project plans, procedures, and work instructions for new statements of work for existing and new clients
Supports the preparation and review of technical proposals
Job Requirements Requirements
Ph.D. with related experience in pharmacology, toxicology, biochemistry, molecular biology, immunology, regulatory affairs, or other applicable field
Solid working knowledge of drug development process and FDA regulatory requirements
Strong management and leadership skills; experience in leading regulatory operations/submissions teams a plus
Direct experience interacting with government regulatory authorities a plus
Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well.
Proficient in Microsoft office; experience with SharePoint a plus.
Superior organizational skills and customer service abilities.
Ability to analyze medical research data and review experimental protocols.
Experience in preparing regulatory documents, publishing regulatory submissions using electronic publishing software and proficiency in preparing documents that are compliant with electronic submission standards is a plus.
Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.