Regulatory Affairs Professional in Pharmaceutical Industry ? A Brief Look
Posted by arun on June 3rd, 2014
As with all industries that deal with human and animal welfare, there are regulatory affairs in pharma industry too. Though these rules and regulations differ from nation to nation, the basic concept remains the same. These rules are made by the government to ensure public health.
Regulatory affairs in pharmaceutical industry create a connecting link between the drug regulation authorities and drug manufacturers. It also helps pharmaceutical companies register their new drug with the authorization agency. A regulatory affairs professional helps companies follow all the requisite steps to the last detail. He/she ensures that all the steps followed during the entire process of creating, manufacturing and testing the drug follow the rules and regulations set by the governmental agency. They should constantly update themselves on the latest developments in the authorization agencies not only in India, but also internationally. This professional should also know the latest guidelines by constantly reading releases and attending national/international conferences. All the changes should be clearly documented for future reference. The professional should also communicate the changes in the regulations to the right people in the company and ensure that the relevant changes are made in the procedure. He/she should also provide expert advice and guidance in seamlessly merging the changes with the existing procedures, so there is no loss of productivity or quality.
Pharma industry regulatory affairs professionals require different sets of skills in different areas of drug manufacturing.Product management: When they are involved in product management, they should concentrate on every aspect from product development to product marketing. They should have a functional knowledge of the guidelines of drug manufacturing in the country and also internationally.
Research & Development: A pharmaceutical industry regulatory affairs professional should keep the R&D department informed about the latest developments in the field of medicine and pharmacology. They should plan and design clinical trials within the budget of the company, and also ensure reliable test results are obtained.
Clinical Trials: In this department, the professional should carefully interpret the guidelines and communicate them clearly to the team. They are also responsible for explaining the various laws and regulations that have to be followed while conducting the clinical trials. He/she should clearly explain to the team the consequences of not following the regulatory affairs of the Pharmaceutical industry.
Regulatory affairs in pharma industry are very stringent and very detailed. The entire investment that a company has made in manufacturing a drug and marketing it could go waste if the regulatory affairs are not followed.
