What is the need for regulatory affairs?
Have you ever wondered who protects public health by ensuring the quality, safety and efficacy of drugs we consume? We all know that a new molecule costs several millions of bucks. At the same time, lack of proper regulation of these drugs can cost several lives. Another thought to ponder is that it takes not less than 15 years to develop and release a new pharmaceutical product. It involves research and development, different phases of clinical trials, regulatory submissions, manufacturing and marketing, distribution and post-market surveillance.
In the meantime, the regulatory environment undergoes dynamic changes. Therefore, it is required to be well acquainted with the ever-changing laws in those countries where the products are supposed to be distributed and marketed. Moreover, the advent and operation of multinational companies and their export of drugs to different countries aroused the need to be aware of regulations laid down by respective governments to facilitate safe and efficient marketing of the drugs.
The Role of Regulatory Professionals
Regulatory affairs is a relatively new field which deals with conducting rigorous regulatory checks of products such as pharmaceutical and veterinary formulations, medical devices, nutritional products, pesticides, agrochemicals, food and cosmetics before they are marketed. Regulatory activities for companies are handled by regulatory professionals who analyse old, existing as well as new regulations in a region with respect to a company’s products, devices and processes, advice on the scientific and legal fronts the constraints and requirements and mediate subsequent negotiations to gain marketing authorizations for the products.
A regulatory professional acts as a liaison between manufacturing companies and regulatory authorities. Right from the beginning of the manufacturing of the product to marketing it the strategic and technical decisions are often taken by senior-level regulatory professionals. This profession just does not involve memorizing regulations but requires analysis of drug market and anticipation of effect of changing regulations on the market.
How to make a career in regulatory affairs?
An undergraduate degree in the fields of life sciences, clinical sciences, engineering, business, public health or even some unrelated disciplines serves to gain entry into the regulatory industry. However, regulatory professionals have a cross-functional training to provide an all-round awareness on the industry. Various universities and well renowned institutes provide online training programs in the field of regulatory affairs. These courses train individuals in various aspects of regulatory affairs governing clinical trials in India and other countries.
Online courses in Regulatory Affairs at James Lind Institute
James Lind Institute (JLI) offers advanced post-graduate diploma in the field of regulatory affairs to explore positions such as Regulatory affairs executive, Regulatory affairs manager, Regulatory affairs associate etc. These programs are self-paced and been designed by the industry experts to meet the end-to-end needs of persistently evolving pharmaceutical companies, CROs and federal agencies.
Technologically advanced e-campus of JLI acts as a contemporary substitute to standard classroom programs. In addition, JLI offer personalized classroom activities through an Online Campus Tutoring Centre, mock drills, tutoring and freelancing opportunities.
For more information please visit: https://www.jli.edu.in/