Chelsea Miller Adds New Breadth to Bracken Expertise in Regulatory Affairs


Chelsea Miller is a recent addition to the Bracken team, one with an unusual background. We talked with Chelsea recently about her career and experience prior to joining Bracken.

ChelseaMiller2021squareQ: You’re a consultant in the Regulatory space. How did you get started in the field?

A: I went to school for political science and specialized in international affairs. My studies touched on how to work with government. After graduation, about six years ago, my husband and I moved to the White Mountains in New Hampshire. There, I began working in Regulatory affairs for a consumer-packaged goods company. A couple years later, I was promoted to Regulatory Manager.

Q: What sort of products did the company produce?

A: It was an outdoor-oriented, multi-brand company, so we focused on OTCs for the kind of injuries you might get outdoors—insect bites, sunburn, things like that. I have a lot of experience in OTC monograph products as a result. On the medical devices side, we created survival kits and first aid kits, all class 1 and class 2 medical devices. We also sold insect repellants, which are regulated through FIFRA (The Federal Insecticide, Fungicide, and Rodenticide Act), and hand sanitizer, which, believe it or not, is classified as a drug. Finally, during my time there, we onboarded a water purification company, which falls under EPA regulations.

Q: What is the process for bringing OTC drugs to market?

A: The interesting thing is that you don’t actually get formal FDA approval for OTC drugs. The FDA doesn’t want to review a million applications for hand sanitizer when it’s well known that alcohol is an effective sanitizing agent. As long as you’re using the right percentage of alcohol, not using any unsafe ingredients, and your product falls within the established rules of the relevant monographs and is produced within GMP, you can just create your label, produce your product, and list it with the FDA.

Q: What was your role in the process?

A: Much of what I did was reviewing product labeling, providing guidance on labels and claims, and writing and auditing drug facts. I also managed the process of listing our products with the FDA. Being that it was a relatively small company, I wore many hats. On any given day, I might be asked to take on anything from working on drafting marketing copy to physically mixing and packaging our products.

Q: You also worked with the Canadian government and its regulations.

A: Yes, I did all our product registrations in Canada—devices, OTC products, and pesticides as well.

Q: Was that significantly different from working with the US government?

A: The Canadian regulations are fairly well aligned with those of the US, but Canada does have all its own registrations, so it’s not automatic that if you have a registration in the US, it will be accepted by Canada.

Q: What have you been working on so far with Bracken?

A: Regulatory IND and NDA submissions, FDA 483 Letters, and I’ve worked on several Orphan Drug Designation submissions.

Q: What else might land on your desk?

A: We’ve discussed device work, and there could potentially be some OTC drug work. I’m not sure if FIFRA would come up, but that is something I’m certainly prepared for. In general, I’ll be helping companies that need an interim Regulatory person or are too small to justify a full-time Regulatory Affairs Manager. A company that produces just one or two regulated products within a portfolio of other products could benefit. I can provide part-time Regulatory assistance to help ensure that such companies stay in compliance.


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