Responsibilities:

• 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, Investigational Device Exemptions (IDEs), Master Files (MFs), other regulatory documents, and International Equivalents (IEs).
• Collaborate with external consultants, clinicians, CROs to provide regulatory guidance.
• Maintain detailed knowledge of global regulatory environment.
• Escalate issues to Management that affect regulatory compliance.
• 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 Snapshot