Lessons Learned from the Regulatory Roles in Industry Panel

This term, the MSL program has been hosting several career advancement-focused events that highlight different paths graduates may take. This week, the focus was on regulatory roles in startups, the pharmaceutical industry, and the chemical industry. The panelists included Erik Eglite, Senior VP, General Counsel & Chief Corporate Compliance Officer at Aurinia Pharmaceuticals; Michael Goldstein,  Program Manager and Clinical Trial Operations Development Program at Abbvie; and Amy Garber Chief IP Officer at Hazel Technologies and a proud MSL alum. The discussion touched on how they got their start in their respective industries, the challenges of internal compliance, and their strategies for approaching SOP.

However, one of the most interesting topics they highlighted was the huge role regulation plays in determining the timeline of a product’s path-to-market. Why? “Regulation plays a big hand in making sure that we’re ethically doing our best in every step of the process, from discovery all the way to the market,” said Michael, a crucial consideration when you work with pharma and biotechnology. Plus, paying attention to regulation helps the bottom line. “You want to get out in the market as soon as possible,” Erik pointed out. “Regulatory is intimately involved in every decision of the process, including the business aspect.” He also mentioned that in certain industries, you’ll need to have an understanding of both national and international regulations in order for your product to be launched in a timely manner. Even if you’re working on your own business model or are part of a startup with a shoestring budget, regulation isn’t something you can or will want to ignore. “The way your business is regulated is essential to figuring out your timeline for your own business,” said Amy. “It costs nothing to contact government officials to ask questions about the process.”

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