Regulatory Specialist II
Location: Bethesda, MD
Founded in 1979, Technical Resources International, Inc. (TRI) provides a unique range of support services in the areas of Communications, Health and Information Technology to both private industry and government agency clients. TRI is currently seeking a Regulatory Specialist to join our Bethesda, MD team.
Essential Duties and Responsibilities:
- Prepare, distribute and track Investigational New Drug Applications (INDs)
- Prepare FDA required IND sponsor’s annual reports
- Prepare scientific and other regulatory documents for submission to the Food and Drug Administration (FDA)
- 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
- Preparation of investigator/pharmaceutical company meeting minutes
- Perform literature searched and extraction of information to support regulatory documents
- Participate in the revisions of SOPs and Work Instructions as necessary
- Handle special client requests as assigned
- Conduct high level quality control review of INDs and other regulatory documents to assure compliance with Food and Drug Administration requirements and guidelines
- Train new staff on Regulatory processes
- Other duties as assigned
- M.S. or Ph.D. or equivalent related experience in pharmacology, toxicology, biochemistry, molecular biology, immunology
- 2-5 years regulatory or related work experience
- Working knowledge of 21 CFR 312, Investigational New Drug Applications and other applicable FDA requirements and guidelines
- Exposure to GCPs and clinical trials a plus
- Excellent oral, written and interpersonal skills
- Ability to analyze medical research data and review experimental protocols
- Working knowledge of word processing, spreadsheet and database management programs
Submit resume with salary requirements to Attn: PH, TRI, 6500 Rock Spring Dr, Suite 650, Bethesda, MD 20817, or fax to (301) 897-1702, or email to [Click Here to Email Your Resumé].
Technical Resources International is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.