| What is Regulatory Affairs???? :- | | | | understanding of the scientific and technical |
| Regulatory Affairs (RA) is an upcoming profession | | | | background of new products. |
| within the biomedical / health products sector. RA | | | | The increasing graph of the global companies’ |
| profession at its heart is all about Collecting, Analyzing | | | | setup in India demands the trained and skilled |
| and Communicating the Risks and Benefits of health | | | | professional on a Handsome Salary, looking back for |
| care products to regulatory agencies and public all | | | | past few years rise in salary is multiplying. |
| over the world. | | | | There is a widening gap of rising demand and too |
| In an organization their prime responsibilities involves | | | | few skilled human resource, this has seen a 50 % |
| preparation and presentation of registration | | | | zoom on average in salaries for skilled manpower |
| documents to regulatory agencies and carry out all | | | | specifically in CRO sector alone. On an average |
| following discussion to obtain and maintain marketing | | | | there has been over 30% rises in salaries in |
| authorization (MA) for the products concerned. | | | | Pharmaceutical Sector. |
| They need to keep a track on ever changing | | | | Research & Development activity in the Pharma |
| legislation in all countries where the companies is | | | | sector is seeing a rapid growth and this growth is |
| looking to market their product. | | | | only poised to increase the need for skilled |
| RA profession is broader than registration of | | | | manpower and higher pay scale to retain the skilled. |
| products, they advise companies both strategically | | | | What you will need to become a RA professional :- |
| and technically at the highest level. Their role begins | | | | - A good background knowledge of the |
| right from development of a product to making, | | | | pharmaceuticals and medical environment |
| marketing and post marketing. Their advice at all | | | | - A meticulous approach to work |
| stages both in terms of legal and technical | | | | - Attention to detail. |
| requirements and restrains help companies save a lot | | | | - Academic Qualification in Regulatory Affairs |
| of time and money in developing the product and | | | | You can expect to work in a multidisciplinary |
| marketing the same. | | | | workplace where scientists and medics will come |
| They have a major contribution in company’s | | | | from very different backgrounds. Excellent written |
| success both Commercially and Scientifically. | | | | and verbal communication skills are a must as is the |
| Careers in Regulatory Affairs:- | | | | ability to work effectively under pressure. |
| Pharma is a highly regulated industry the world over | | | | Global Institute of Regulatory Affairs (GIRA) |
| and professionals, who can manage regulatory affairs, | | | | GIRA has developed a Post Graduate Diploma |
| are in high demand. | | | | (Sunday batches) and Advanced P.G. Diploma in RA |
| Selling drugs is not like selling anything else, when we | | | | (Full Time) which will surely help the professionals as |
| sell drugs we need to be confident that | | | | the program address regulatory Affairs within each |
| - They do what they claim to do | | | | category of regulatory agencies of various country, |
| - They have been through a tough testing process | | | | Drugs and Medical devices. |
| to get from the lab to the market | | | | This Program will be a complement to those who |
| - The side effects are well documented | | | | carrying Science, Pharmacy and Health related |
| | | | | degrees, there are many rewarding career |
| This is where regulatory affairs come in. | | | | opportunities with regulatory affairs for individuals |
| “Regulatory Affairs Professional is the key link to | | | | with a variety of backgrounds. |
| distributing your drugs to world region.” | | | | The courses has been developed, under the guidance |
| The Indian Pharmaceutical industry is one of the | | | | of Industry and Government Experts, to provide |
| fastest growing industry in India, with a CAGR of | | | | broad regulatory foundations, exposure to the |
| over 13 % in last 5 years and it is expected to grow | | | | practical, real-world applications of the regulations, and |
| at a higher rate in coming 10 years. It is valued at $ | | | | an appreciation of the important roles that regulatory |
| 8.0 billion approximately and ranks 4th in terms of | | | | affairs professionals play in the bioscience industry. |
| volume and 13th in terms of value globally. | | | | Courses are taught by experienced regulatory |
| With such a high growth rate and rapid globalization | | | | professionals currently working in device, diagnostic, |
| there is a substantial need for highly trained | | | | pharmaceutical and biologic sectors. Instructors bring |
| professionals ready to perform the work required | | | | the regulations to life and infuse their courses with |
| within this specialized industrial sector who will keep | | | | relevant examples and hands-on exercises designed |
| updates with regulatory law, policies and procedures | | | | to prepare students for rewarding careers in |
| for one or more product lines as well as maintain an | | | | regulatory affairs. |