Working in regulatory affairs is not a simple task to do. There are two kinds of job area for regulatory affairs. They are local and international. In Latin America, all of the regulatory affairs specialists should know the strategies of regulatory and implementation of the product. Regulatory affairs services Latin America should respond to narrowly the focus on a specific country or region. The country or region to handle should contain the specialist's proficient language skills including reading, writing, and speak. It is because they need to speak, write, and read in the business level region.
The aim of using regulatory affairs services Latin America is to get the point in the business level region of communicating with regulatory authorities and international local offices or distributors. The specialists will develop the regulatory strategies, serve as a communication liaison, and maintain approvals between the manufacturer, local office, and distributor. What is the full job description of the specialist?
Regulatory affairs services Latin America should able to communicate region-specific regulatory requirements and assist with the regulatory strategies. The specialists have to obtain, maintain, and develop regulatory strategies. Make a plan and prepare regulatory submissions for new products also their task to do, including re-registrations for the specific regions. When it is necessary, regulatory affairs specialists should maintain registration information like license numbers, perform translation activities, and obtain re-registration approvals. It is good when the specialists can collaborate with regulatory scientific affairs in order to land on handling all high-risk devices and new technologies. The specialists are able to collaborate with the Clinical Functional Unit and provide support to currently marketed products. They also need to maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.
Based on the whole job description above, the company who use regulatory affairs services will get helped in regulatory authorities because the specialists will ensure the product approvals. They will make sure if it will be achieved in a timely manner. There will be no more complicated procedure if the company use regulatory affairs services, especially in Latin America which most of its area have many intellectual properties to protect. It is good to have a Latin American person in this working area because he has a good Latin American’s speaking skill. Anyone who desires in this job description should graduate from a bachelor degree in a life science and travel less than 10% annually. If you have this service, you will have a smooth way to announce your product.