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Director of Regulatory Affairs
RAC holder since 2017
My most common activities include writing/editing/reviewing protocols for chemistry, manufacturing, and control, as well as preclinical and clinical studies. For instance, in the past week I have advised on the design of a nonclinical toxicology study to support an IV product, done risk evaluation of a stability program for a Phase 1/2 product, and reviewed multiple clinical protocols.
In the past year, having the opportunity to contribute to multiple COVID-19 products in development. At one point, we completed an entire IND in 30 days.
The Regulatory Exchange (RegEx) open forum has been by far the most helpful RAPS benefit. I post and review/respond to posts regularly there. I have had many specific circumstantial questions answered, such as how to audit a database for a Phase 1 study.
Acknowledge that it will take considerable time (10 or more years) to become broadly proficient in regulatory affairs, based on the variety of exposure that comes with the profession.