Regulatory Operations Manager - Clinical Research
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POST DATE 8/31/2016
END DATE 10/23/2016
Technical Resources International Inc.
JOB DESCRIPTIONThe 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