What are regulatory and clinical affairs?
The job of regulatory and clinical scientists is to keep people safe.
Regulatory affairs and clinical development are parts of the biotech pipeline that come after discovery research and before the product can be used out in the world (which is most of that pipeline!) In this way, scientists in regulatory and clinical careers are important gateways. The main purpose of this gateway is to keep people safe: Clinical scientists do this by determining the indications, dose, and treatment population through clinical trials; Regulatory affairs do this by liaising between companies and health authorities. There is a wide range of jobs within this sector, all goal-oriented toward developing a product that can have positive impact on the world. These careers are often lucrative, have good job security, provide pathways to many other career fields, and have opportunities for advancement for those with MDs or PhDs.
Regulatory Affairs
Regulatory affairs (RA) scientists are involved with overseeing the process of getting a drug or product through the FDA review and approval process and onto the market. Since every step in the process of product development is highly regulated, those in RA work at each step to move a drug from research and development through FDA approval. They act as liaison between companies and the Food and Drug Administration (FDA). The FDA also has a webpage for advancing Regulatory Science with details on this field, the FDA's strategic plan, and resources for people interested in careers in regulatory affairs.
The Science article "All in the Details: Careers in Regulatory Science" describes regulatory science as "the art and science of taking new medical and food products to market and keeping them on the market, under the constraints of a variety of laws and requirements. You're doing science, but you're doing it in a legal framework." Due to the large scale and nuance of this work, a senior regulatory scientist stated that "Anyone who has an interest in the regulatory field must have a pronounced love of detail." Learn more about the tasks in regulatory work and what it takes to succeed in them from this Science article.
Clinical research
Clinical research work is directly related to patient outcomes, such as in clinical trials. Clinical trials can be run either by companies or in academia. PhDs have many transferrable skills that are highly relevant to clinical research, so clinical research teams are often led by PhDs, with no requirement for an MD. People in the clinical research field feel that their jobs are highly impactful, as they are at the very forefront of where science becomes medicine that can improve patients' lives. Clinical research is a broad field with many different roles in it. Learn about these roles as well as how PhDs can transition into this industry in the Interdisciplinary Job Opportunities for Biomedical Scientists blog from Rutgers.
Regulatory and Clinical Affairs - The Fundamentals
Get a quick overview of regulatory and clinical affairs careers from UCSF alums working in the field
Regulatory and Clinical Affairs Alumni Career Paths Panel featuring UCSF alums Patrick Heiser, PhD and Brandi Saunders, MS.
Get hands on exposure to regulatory and clinical affairs careers with an
Learn about the expectations of people in different roles within the regulatory field in this article from the Regulatory Affairs Professionals Society, and this interview with the department chair for regulatory affairs at Northeastern University. Some of the responsibilities of RA is writing and working in teams, so your project management and communication skills from your PhD will come in handy. For both clinical research and regulatory science, attention to detail and ability to keep both the details and the big picture in focus at the same time is useful. Like in research science, regulatory and clinical scientists are constantly learning and are often on the cutting edge of medicine, dealing with "first of a kind" therapies. In both fields, working well with giving and receiving feedback is critical to help processes move as quickly and smoothly as possible, which is important because in these fields, there is always more to do!
For clinical research, understanding on clinical trial processes is crucial, including Good Clinical Practice (GCP). Since these trials are so highly regulated, everyone on the team must have a thorough understanding of the guidelines that clinical trials must follow. Learn more about what a clinical research scientist’s job looks like in BiteSizeBio's article on clinical research.