Regulatory Specialist
Technical Resources International, Inc.
Summary
Prepare, distribute, and track regulatory submissions including drug and biologic Investigational New Drug Applications (INDs), Biologics License Application (BLAs), New Drug Application (NDAs), Investigational Device Exemption (IDEs), ensuring compliance in accordance with GCPs/ICH and all applicable FDA/other Regulatory Health Authority regulations.
Job description
Job Description
Prepare, distribute, and track regulatory submissions including drug and biologic Investigational New Drug Applications (INDs), Biologics License Application (BLAs), New Drug Application (NDAs), Investigational Device Exemption (IDEs), ensuring compliance in accordance with GCPs/ICH and all applicable FDA/other Regulatory Health Authority regulations.
Prepare scientific and other regulatory documents for submission to the Food and Drug Administration (FDA) and other Health Authorities.
Attend scientific meetings and review the literature to stay current with new developments in the infectious disease field (in particular, human immunodeficiency virus (HIV) and tuberculosis (TB)) and therapeutic clinical research.
Perform literature searches, attend meetings, etc. as needed to support regulatory document preparation, regulatory intelligence, and regulatory strategy, and to stay current with applicable therapeutic areas of clients.
Job Requirements
- Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well.
- Ability to analyze medical research data and review experimental protocols.
- Strong working knowledge of Microsoft Office; experience with SharePoint a plus.
- Professional or educational background in a scientific field, clinical trials, regulatory affairs or health care; familiarity with GCP and/or experience working in an FDA-regulated environment is desirable.
- General knowledge of the drug/vaccine development process or clinical trials is a plus.
- Experience in preparing regulatory documents, publishing regulatory submissions using electronic publishing software and proficiency in preparing documents that are compliant with electronic submission standards.
This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.
Requirements
- Excellent oral and written communication skills
- Detail-oriented and able to multi-task/prioritize well
- Ability to analyze medical research data and review experimental protocols
- Strong working knowledge of Microsoft Office
- Experience with SharePoint a plus
- Professional or educational background in a scientific field, clinical trials, regulatory affairs or health care
- Familiarity with GCP and/or experience working in an FDA-regulated environment is desirable
- General knowledge of the drug/vaccine development process or clinical trials is a plus
- Experience in preparing regulatory documents
- Experience publishing regulatory submissions using electronic publishing software
- Proficiency in preparing documents compliant with electronic submission standards
Company overview
Technical Resources International, Inc. (TRI) is a leading contract research organization plus (CRO+) founded in 1979 and headquartered in Bethesda, Maryland. As a certified Hispanic woman-owned business, TRI provides comprehensive product development support services to pharmaceutical, biotechnology, vaccine, medical device, and healthcare sector clients worldwide. The company specializes in the effective integration of scientific, clinical, information technology, and communication services to accelerate drug development and regulatory approval processes. TRI offers end-to-end solutions including clinical trial management across all phases (I-IV), regulatory strategy and operations, biostatistics, data management, medical writing, and safety monitoring. With over four decades of experience, TRI has established itself as a trusted partner to both public and private sector clients, including major government agencies like the National Institutes of Health (NIH) and National Cancer Institute. The company's success is built on its staff's scientific expertise, client-focused approach, and proven track record of delivering high-quality services that meet regulatory standards and accelerate time-to-market for innovative therapies.