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What Regulatory Affairs

What Regulatory Affairs

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Published by sumit_gup01

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Published by: sumit_gup01 on Apr 06, 2010
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What is Regulatory Affairs???? :-
Regulatory Affairs (RA) is an upcoming profession within the biomedical / healthproducts sector. RA profession at its heart is all about Collecting, Analyzing andCommunicating the Risks and Benefits of health care products to regulatory agenciesand public all over the world.In an organization their prime responsibilities involves preparation and presentation ofregistration documents to regulatory agencies and carry out all following discussion toobtain and maintain marketing authorization (MA) for the products concerned.They need to keep a track on ever changing legislation in all countries where thecompanies is looking to market their product.RA profession is broader than registration of products, they advise companies bothstrategically and technically at the highest level. Their role begins right fromdevelopment of a product to making, marketing and post marketing. Their advice at allstages both in terms of legal and technical requirements and restrains help companiessave a lot of time and money in developing the product and marketing the same.They have a major contribution in company’s success both Commercially andScientifically.
Careers in Regulatory Affairs:-
Pharma is a highly regulated industry the world over and professionals, who canmanage regulatory affairs, are in high demand.Selling drugs is not like selling anything else, when we sell drugs we need to beconfident that
 They do what they claim to do
 They have been through a tough testing process to get from the lab to the market
 The side effects are well documented
This is where regulatory affairs come in.
“Regulatory Affairs Professional is the key link to distributing your drugs to world region.” 
The Indian Pharmaceutical industry is one of the fastest growing industry in India, with aCAGR of over 13 % in last 5 years and it is expected to grow at a higher rate in coming10 years. It is valued at $ 8.0 billion approximately and ranks 4
in terms of volume and13
in terms of value globally.With such a high growth rate and rapid globalization there is a substantial need forhighly trained professionals ready to perform the work required within this specializedindustrial sector who will keep updates with regulatory law, policies and procedures forone or more product lines as well as maintain an understanding of the scientific andtechnical background of new products.The increasing graph of the global companies’ setup in India demands the trained andskilled professional on a
Handsome Salary
, looking back for past few years rise insalary is multiplying.There is a widening gap of rising demand and too few skilled human resource, this hasseen a 50 % zoom on average in salaries for skilled manpower specifically in CROsector alone. On an average there has been over 30% rises in salaries inPharmaceutical Sector.Research & Development activity in the Pharma sector is seeing a rapid growth and thisgrowth is only poised to increase the need for skilled manpower and higher pay scale toretain the skilled.
Regulatory Affair Pathway :-
Regulatory Affairs Career Models/Pipeline0-2 Year’s Experience 2-5 Year’s Experience 5-15 Year’s ExperienceRegulatory AffairsExecutive, RegulatoryAffairs Officer, RA Officer(Production), Officer QualityAssurance,B Pharm/ M Pharm/Graduate/post-Graduate(Chemistry)Manager RegulatoryAffairs, Project Manager.Quality Assurancemanager.CEO, General ManagerRegulatory Affairs,Administrative RegulatoryAffairs, Heads project,Technical Director,Consultants.
What you will need to become a RA professional :-
 A good background knowledge of the pharmaceuticals and medical environment
 A meticulous approach to work
 Attention to detail.
 Academic Qualification in Regulatory AffairsYou can expect to work in a multidisciplinary workplace where scientists and medics willcome from very different backgrounds. Excellent written and verbal communicationskills are a must as is the ability to work effectively under pressure.
Global Institute of Regulatory Affairs (GIRA)
GIRA has developed a Post Graduate Diploma (Sunday batches) and Advanced P.G.Diploma in RA (Full Time) which will surely help the professionals as the programaddress regulatory Affairs within each category of regulatory agencies of variouscountry, Drugs and Medical devices.This Program will be a complement to those who carrying Science, Pharmacy andHealth related degrees, there are many rewarding career opportunities with regulatoryaffairs for individuals with a variety of backgrounds.The courses has been developed, under the guidance of Industry and GovernmentExperts, to provide broad regulatory foundations, exposure to the practical, real-worldapplications of the regulations, and an appreciation of the important roles that regulatoryaffairs professionals play in the bioscience industry.Courses are taught by experienced regulatory professionals currently working in device,diagnostic, pharmaceutical and biologic sectors. Instructors bring the regulations to lifeand infuse their courses with relevant examples and hands-on exercises designed toprepare students for rewarding careers in regulatory affairs.GIRA is a Division of “Perfect Pharmaceutical Consultants Pvt Ltd” – providingintelligent regulatory solutions since last 20 yearsPlease contact below for “FREE Counseling”
Contact Details:-
Global Institute Regulatory Affairs (GIRA)

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