Graduate Regulatory Affairs Jobs, Employment - May 2020.
The Professional Program in Regulatory Affairs reviews FDA regulations and other guidelines, Good Pharmaceutical Practice (GXP) principles and ethical considerations covering the development of drugs and dossiers for clinical trials and licensure, and provides the training to manage these activities. Next Steps. Get More Information. Expand or collapse section. Straight to your inbox each.
Whether you realize it or not, you cross paths with the regulatory affairs industry on a daily basis. In fact, 25 cents of every dollar spent by American consumers go toward a product or service regulated by the Food and Drug Administration (FDA). Each food, beverage, cosmetic, prescription medication, or vitamin you purchase has undergone rigorous regulatory checks for safety and efficacy on.
Regulatory affairs professional with wealth of experience in operations, consultancy and strategy. Resolute manager whose added value is his ability to think scientifically, incessantly monitor changes in the regulatory environment, disseminate regulatory intelligence to serve diversified company needs. Executive whose ability to function in matrix organisations ensures seamless communication.
Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods).
PhD Career Guide discusses some of the roles, entry points, career progression, and compensation expectations for careers in regulatory affairs. Some of the responsibilities of RA is writing and working in teams. The scientific background of PhDs is useful for the FDA product approval process; more information in Toby Freedman’s book. For clinical research, understanding on clinical trial.
Patrick Ginty PhD, RAC(US) Regulatory Affairs Professional and Cell and Gene Therapy Specialist London, United Kingdom 338 connections. Join to Connect. Cell and Gene Therapy Catapult. Report this profile; About. Currently leading the regulatory affairs department at Cell and Gene Therapy Catapult, providing regulatory services and leadership to the cell and gene therapy community. 15 years.
The Regulatory Affairs Certification (RAC) is the only certification specifically for regulatory professionals in the healthcare product sector, which is obtained by passing a rigorous exam. Obtaining the RAC is not critical for employment in the regulatory field (approximately 5,000 individuals have one to date), but it serves as recognition of professional achievement and is correlated with.