First earning an Associate of Science from the Community College of Baltimore County, Kendra Grichuhin initially intended to pursue a career as a nurse, but rapidly fell in love with the sciences, particularly microbiology, while taking her nursing pre-requisite courses. She continued her studies with a Bachelor of Science from the University of Charleston in West Virginia and culminated her education with a Master of Science in microbiology from the University of Iowa in 2006. From there, Ms. Gichuhin returned to her early thoughts of a career in health care, this time turning her focus to laboratory research.
Ms. Grichuhin joined Vanda Pharmaceuticals in 2013, where she spent her first two years doing work with genotyping samples. She then concluded her tenure with the company as a regulatory and QA manager from 2015 to 2016. Joining Supernus Pharmaceuticals, Inc. in 2020, she achieved the position of director of regulatory affairs in 2021. In the two years she has been with Supernus, the company has practically quadrupled in size and, looking toward the future, Ms. Grichuhin hopes to continue to rise within the company to the point where she will eventually have the opportunity to run her own department.
Holding considerable expertise in communications and submissions with the Food and Drug Administration, Ms. Grichuhin also excels in developing strategies for their clinical development programs in regard to Food and Drug Administration regulations. When she first started with Supernus, they had two products on the market, Trokendi XR and Oxtellar XR, two drugs designed to treat epilepsy. She was made the regulatory representative of the Oxtellar XR program as well as for the investigatory program for Molindone, an ADHD medication, and the regulatory and program lead for the development of a novel mechanism of action for a drug to treat treatment-resistant depression. In April 2021, an ADHD medication that she had been the regulatory lead of the program for was approved for use in the United States.
Ms. Grichuhin has been incredibly grateful to the mentors she has had throughout her career. Prior to entering the area of regulatory affairs, she hadn’t had much experience in the clinical side of the field. It has been thanks to her excellent mentors, including her supervisor at Supernus, the senior vice president of regulatory affairs, that she picked up the requisite skills so quickly. Attributing much of her success to her drive and her desire to excel in her work, Ms. Grichuhin considers her favorite aspect of her career to be bringing products to market that will help patients, noting that there is nothing more gratifying than seeing a project you have been working on for years get approval.
For her excellence, Ms. Grichuhin was inducted into TriBeta, the national biological honor society, and also maintains professional affiliation with the Regulatory Affairs Professionals Society in order to keep up to date with new developments in the field. Having accomplished much over the course of her career, she considers her professional highlight to be the fact that she has been involved in three projects that have received regulatory body approvals, two new drug application approvals and one marketing authorization application approval. She recalls that when the first approval happened, the approval letter was privileged information, so she and her team spent the entire day the letter arrived checking to see if the announcement press release had been posted. Having three product approvals is an incredible accomplishment, as many professionals go through their whole careers without getting a single submission approved.
In addition to her work, Ms. Grichuhin is incredibly dedicated to her family. She strongly believes that women can have successful careers and families at the same time. Born in Maryland with two older sisters, she has been married to her husband for many happy years and is the proud mother of two sons. She hopes to leave a legacy as someone who always done her utmost to pay forward what she was given and now strives to be a mentor to the upcoming generations of professionals entering the field. Ms. Grichuhin ultimately defines success as having happiness in your career, life and family.
