Technical Resources International, Inc. ยท 6 days ago
Regulatory Specialist
Bethesda, MD
Full-time
Hybrid
New Grad, Entry LevelTechnical Resources International, Inc. is seeking a Regulatory Specialist to prepare and manage regulatory submissions for drug and biologic applications. The role involves ensuring compliance with regulatory standards and staying updated on developments in infectious diseases.
Data ManagementInformation Technology
Responsibilities
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 reviews 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
Performs 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
Qualification
Required
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 reviews 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
Performs 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
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
Company
Technical Resources International, Inc.
Technical Resources International is a pharmaceuticals company offering biostatistics and clinical data management services.
Founded in 1979
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase