Marshall Hoke

Marshall Hoke

Director of Regulatory Affairs
Lafayette, CO

RAC holder since 2017

 

What is a typical day like for you?

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.

What was an especially memorable moment for you on the job?

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.

How has earning your RAC and/or your membership in RAPS helped you?

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.

What advice would you give to someone looking to start a career in regulatory?

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.

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