What are the responsibilities and job description for the Regulatory Specialist position at Technical Resources International, Inc?
Job Title
Regulatory Specialist
Location
Bethesda, MD 20817 US (Primary)
Category
Regulatory Affairs
Job Type
Full-Time
Salary Range
75,000.00-85,000.00 / YEAR
Education
Bachelor's Degree
Travel
None
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 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.
Job Requirements
We are equal opportunity / affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.
