Drug Regulatory Affairs refers to all aspects within the pharmaceutical development process and how they are subject to various degrees of regulation. Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking.The role of regulatory affairs is to develop and execute a regulatory strategy to ensure that the collective efforts of the drug development team results in a product that is approvable by global regulators but is also differentiated from the competition in some way and also is to ensure that the company's activities.
Regulatory Affairs Specialists assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials. They are often employed by pharmaceutical, biotechnology, and medical device companies. They may also work in government or law.The main objective of regulatory affairs is to provide the basis for the assurance of high quality of food products which can increase consumer's interest for ensuring the efficacy, quality, and safety.
A detailed account of these basic steps follows.
Step 1: Earn a bachelor's degree (4 years). ... Step 2: Get practical experience in the field (1 – 4 years). ... Step 3: Complete advanced coursework in regulatory affairs (1 – 5 years). ... Step 4: Obtain certification (several weeks or months).