In this article, we shine the spotlight on Quin Christensen, Senior Consultant at NDA.
Regulation as a rescue: Navigating rules as pathways to care
For Quin Christensen, Senior Consultant at NDA, an unlikely path led to a passion for helping others. With experience spanning military service, academia, and biotechnology, Quin’s diverse background equipped him with a unique perspective. It was not until crossing into regulatory affairs that he found his true calling.
“I served in the army part-time throughout my undergraduate programme and partly into my PhD. Since I was an enlisted mechanic, it was kind of weird to stop by the lab for microbiology experiments on the weekends while wearing my battle-dress uniform and then go to the armoury to get underneath a HMMWV, but it turns out that the two are related. In one case, I was attempting to understand how bacteria work, and in the other case I was trying to understand why a vehicle doesn’t work; both are hypothesis testing to generate new knowledge.”
Quin’s strong interest in science was sparked early in life. “I didn’t initially consider manufacturing regulatory affairs, but the fact that growing up I enjoyed reading about my breakfast cereal ingredients is telling”. He worked in different academic labs for 11 years—at one point having the good fortune to discover a new enzyme. After initially considering continuing in academia, he decided to transition into industry and apply what he learned there. He worked at a biofuel company and for a defence contractor, where he applied his expertise in bacterial metabolism and genetic engineering. “It wasn’t a great fit because I found myself reading much more widely than the job required”. Quin continued to explore different career opportunities, including considering becoming a patent agent.
However, he ultimately landed a job at a company that focused on cell and gene therapy product development, and that was where he discovered a passion for pharmaceutical regulatory affairs and chemistry, manufacturing and controls (CMC). “I applied for a job as a medical writer, which is someone that is more of a clinically minded regulatory writer. But during my interview, the company said they needed help writing the quality section of a marketing application for a new gene therapy product and that I had a great background for that. I accepted the role, and it turned out to be a great fit,” Quin recounted, “I am also fortunate to have found a number of great mentors over the years.”
Enabling innovation through information integration
Quin describes his passion for regulatory CMC as an accidental discovery rather than a planned or deliberate path. The opportunity for continuous learning and contributing to public health were key factors that inspired his passion in this area.
“My passion for regulatory CMC grew over time because of my love for researching and writing. The depth and breadth of knowledge required for regulatory CMC is almost endless, so I am constantly improving my knowledge. I also found it fascinating to explore different topics, like statistical methods for sampling, material choices for medical devices, and how they can impact safety. I think that regulatory CMC allows me to contribute to the development of safe and effective medicinal products, which improve the lives of patients.”
Quin’s passion led him to NDA, where he applies his expertise in regulatory CMC to help clients navigate the complex regulatory landscape of drug development. As a Senior Consultant, Quin’s role involves client interactions, managing project execution, and ensuring compliance with regulatory requirements. “I enjoy working with NDA clients because it gives me the opportunity to provide solutions to diverse clients from across the globe. Every client brings a unique set of challenges which exposes me to new learning opportunities,” Quin said. His decision to work at NDA was driven by the company’s employee-focused culture and established brand in regulatory consulting.
“NDA has a reputation for high quality work and has a strong track record in regulatory consulting. I think these features make it an attractive choice for anyone seeking a career in regulatory consulting.”
Quin is pleased to be working in a supportive and collaborative environment where colleagues with diverse skills and expertise work together on projects. In his own words, “NDA has a very supportive and collaborative culture that fosters high quality results. Not only amongst my immediate colleagues, but throughout the company.”
Nurturing quality and safety
Quin describes regulatory CMC as the regulation of pharmaceuticals, particularly focusing on their manufacturing and testing processes.
“I think that anyone looking to specialize in this field needs to be highly collaborative and communicative because they will often collect information from various sources and must convey it effectively. Reading and writing skills are also important in regulatory CMC for summarizing complex technical information in the most efficient way.”
Quin concluded by highlighting how regulatory CMC is relevant for drug developers across various stages of drug development. He explains the importance of regulatory CMC especially in the areas of complex biologics, advanced therapies, and biosimilars.
“Regulatory affairs is an important consideration for the drug development process in that it ensures different efforts are working together toward safety and efficacy. As technology advances and more complex biologics emerge, the importance of regulatory CMC will continue to grow.”