In this episode of Chasing Compliance, host Jamie Hijmans sits down with Carrie Eklund, Senior Manager of Chemistry, Manufacturing, and Controls or CMC at Global. Over the course of the episode, Carrie discusses how her start as a research scientist prepared her for a career in CMC regulatory affairs. A self‑described “lab rat” who loves her job because she gets to “nerd out” every day, Carrie’s passion for science and regulatory affairs is apparent as she discusses her role at Global and how she and her team have used their combined experience to surmount the challenges associated with working as 3rd party CMC writers and consultants. She also discusses her team’s experience with a wide range of regulatory documents, such as, biological licensing applications, investigational new drug applications, drug master files, agency correspondence, biosimilars, first‑in‑class treatments, vaccines, and more. She provides insight on some common mistakes made by CMC writers, tips for navigating challenging regulatory scenarios, and the value of teamwork and a great team culture. On the lighter side, Carrie discusses why she loves working at Global, work in the time of COVID, her ideal Friday night, and how she maintains her work-life balance.

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“What did the council decide on item 42?” — answered with the speaker and the moment.

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