Regulatory Specialist/Senior Associate

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POST DATE 8/31/2016
END DATE 10/23/2016

Technical Resources International Inc. Bethesda, MD

Company
Technical Resources International Inc.
Job Classification
Full Time
Company Ref #
355601
AJE Ref #
576029914
Location
Bethesda, MD
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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This position is part of a team supporting government-sponsored clinical trials. The key responsibilities include:
Draft pre-IND packages, FDA correspondence, and other regulatory submissions in support of active and planned investigational applications (INDs, NDAs, BLAs, IDEs, etc.)
Prepare regulatory submissions using electronic submission publishing software, to be submitted to the FDA s Electronic Submissions Gateway
Review protocols for compliance with regulatory requirements
Abstract document information into database(s), maintaining files for regulatory documents, preparing contract required reports, and participating in the revision of work instructions
Cross-train into other areas of the regulatory support project