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HOW TO GET A JOB IN REGULATORY AFFAIRS?

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Department of Regulatory Affairs is a crucial part of any pharmaceutical, biopharmaceutical, medical device, nutraceuticals, veterinary, and cosmetic industry. The department is focused on maintaining the quality standards and safety of medicinal products in different markets around the world. To make this possible, the regulatory professionals keep a close eye on all the products on various parameters such as development, manufacturing, testing, and distribution. This department also works closely with the government authorities to regulate the activities of the company. A career in regulatory affairs offers immense opportunities and growth for students keen to learn and acquire knowledge.   Skills Required for Regulatory Affairs The rules and regulations around the world are different for every region around the world. These rules are much more stringent for pharmaceutical and medicinal products owing to the safety of the public. Hence, regulatory professional has to be on their toes
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Pharmacovigilance Job Opportunities In Top Companies

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  The pharmaceutical and healthcare sector has grown tremendously in the past few years. Which, pharmacovigilance is coming out as a viable option for students to build a stable career. The career growth and opportunities in Pharmacovigilance are immense. Pharmacovigilance aims to gather, understand, assess, and prevent adverse effects of a drug or medicinal product. This is done by various processes such as 1. Individual Case Safety Reports (ICSR). 2. Clinical Review of Safety Reports. 3. Cohort Event Monitoring. 4. Longitudinal Electronic Patient Reports. 5. Periodic Safety Update Reports (PSUR). 6. Spontaneous Recording. 7. Record Linkage. 8. Expedited Report. A candidate in pharmacovigilance performs the following functions: 1. Reporting adverse events received from customers or healthcare bodies. 2. Reducing the risk of serious side effects. 3. Creating and reviewing serious adverse effects reports. 4. Performing safety audits. Types of Companies Hiring in Pharmacovigilance Pharma
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HOW TO BECOME A SUCCESSFUL REGULATORY AFFAIRS PROFESSIONAL IN MEDICAL DEVICE FIELD ?

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  The medical device industries work in tandem with the pharmaceutical industries by providing innovative solutions to improve patient outcomes. The companies either innovate by updating the existing technology or developing a new device. These devices provide a means for the effective treatment of a particular disease or condition. A regulatory affairs professional performs a critical role in the medical device lifecycle-right from the innovation of the device to the device reaching the physician. It includes   medical device compliance training , leading premarket strategy, drafting regulatory submissions, and ensuring post-marketing compliance. As all of these activities are scrutinized, it demands a professional with a specific set of skills. If you wish to set your foot in this domain, here are the skills you need to watch out for: 1. Regulatory Knowledge Usually, a degree in any field of science with  regulatory affairs medical device courses  may pave the way into entry-level jo
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INDIAN PHARMACY INDUSTRIES

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  The Indian pharmaceutical industry is a success story providing employment for millions and ensuring that essential drugs at affordable prices are available to the vast population of this sub-continent. - Richard Gerster The Indian Pharma Industry has been growing at a rapid space in the last 4 -5 years, according to a McKinsey Report India Pharma 2015 the industry is expected to grow at a CAGR of 16% for the period of 2007-2011. The growth and development of Indian Parma industry has seen India on the world map, today India has gained the reputation of producing high quality low cost generics. Indian Pharma Industry has more than 20,000 registered units producing drugs. India also has the largest numbers of US FDA approved plants outside USA. India has become the favored destination for all sought of Pharmaceutical activities, out of this Research & development and Clinical Research are the front runners. This increase is Pharmaceutical activities has seen a major demand for ski
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Prospects of Pharma Industry

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  WHO defines Pharmacovigilance (PV) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Pharmacovigilance is also known as drug safety and it focuses on ADR (Adverse drug reaction)
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REGULATORY AFFAIRS PROFESSION AND CAREER

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What is Regulatory Affairs? RegulatoryAffairs (RA) is a profession within the health care industry namely, Pharmaceutical, Medical Device, Biologics, & Functional Food. Regulatory Affairs can be defined as It means government affairs Their main role is to comply with Safety & Efficacy of the products as per regulation laid down by the government. They advise companies on all regulatory aspects and laws pertaining to their business such as the promotion of the prescription drug. RA profession at its heart is all about Collecting, Analyzing and Communicating the Risks and Benefits of health care products to regulatory agencies and public all over the world.. In an organization their prime responsibilities involves preparation and presentation of registration documents to regulatory agencies and carry out all following discussion to obtain and maintain marketing authorization (MA) for the products concerned. They need to keep a track on ever changing legislation in all coun
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