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Regulatory Operations Manager - Clinical Research

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

Technical Resources International Inc. Bethesda, MD

Location
Bethesda, MD
AJE Ref #
576029890
Job Classification
Full Time
Job Type
Regular
Company Ref #
360537
Experience
Entry Level (0 - 2 years)

JOB DESCRIPTION

The key responsibilities include:

Overseeing and managing electronic regulatory submissions in support of active and planned investigational applications (INDs, NDAs, BLAs, IDEs, etc.)

Applying knowledge of electronic publishing requirements to ensure compliance with agency submission requirements

Remaining current with evolving standards for electronic submissions

Training team members on how to prepare and submit electronic document packages (e.g., formatting documents, publishing using electronic submission software, submission through the FDA s ESG)

Keeping abreast of regulatory procedures and changes