Perspective: The RAC General Scope Exam or: How I Learned to Stop Worrying and Love GHTF Guidelines

Posted 01 May 2010 | By

Like many of my colleagues, I came to regulatory by happenstance. My company was preparing its first new drug application (NDA) and it was all hands on deck to get the big submission out the door. I enjoyed the excitement of assembling a submission that was essential to my company's success. Lab work had never been this exciting! (Except maybe the time I spilled the glacial acetic acid and the Hazmat team arrived, but that was exciting in the wrong way.) Regulatory work was important!

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