The professional figures that move within Regulatory Affairs are mainly concerned with supervising the authorization procedures for the marketing of the products of pharmaceutical companies.
The Regulatory Affairs sector arises from the desire of government bodies to protect public health by monitoring the safety and efficacy of pharmaceutical industry products. On the other hand, the companies responsible for research and production of drugs, veterinary products, pesticides, para-pharmaceuticals, and cosmetics want their products to be in line with current safety regulations and rely on an internal department or on expert advisors in Regulatory Affairs.
Tasks and main activities
The figure of the regulatory affairs training courses USA is close to the figures in the Marketing-Chemical-Pharmaceutical industry, also in the role of Documentation Manager. Therefore, the Regulatory Affairs Officer acts as an intermediary between the authorities’ requests and the needs expressed by all the functional areas of the company. When submitting an application for the placing on the market of a product, the company must prepare, in support of the authorization request, specific documentation, divided into three sections:
Chemistry, in which the production process is described;
Pre-clinical, containing preliminary studies to assess the safety and efficacy of the drug;
Clinical research, containing human studies demonstrating the validity of the product to be marketed for the prescribed therapeutic indication.
The work of the Regulatory Affairs Officer differs fundamentally in two moments:
The preparation of the dossiers in line with the current legislation on the subject, and the drafting of the documentation to support the application for marketing authorization;
Mediation and interface between the company and the ministerial bodies that examine the documentation.
In a competitive environment such as the pharmaceutical industry, the expertise of the experts working in the Regulatory Affairs sector is, therefore, of considerable economic importance for the company.
Working in regulatory affairs
Regulatory affairs study in USA play an essential role in protecting the health and well-being of millions of people around the world. They are important in many areas: drugs, medical devices, supplements, food, and cosmetics. Each of these sectors presents its own regulatory framework, and the offer of positions is not lacking.
At the beginning of the career, qualifications, skills, and experience are all the same, but it can be difficult to understand how qualified and competent one is or how much experience our potential employer is looking for.
What training? What qualifications?
As a rule, to enter the world of regulatory affairs, it is necessary to obtain a degree in a scientific subject, especially those more related to pharmaceutical development, such as chemistry and pharmacy. The Master in Management & Marketing of the Pharmaceutical Industry can be a nice advantage and a good way to specialize in Regulatory Affairs, especially if the course of study was more general.
Moreover, since the world of regulatory affairs is in continuous progression, periodic refresher and training courses on regulatory changes are also recommended.
Finally, keeping yourself informed about what is happening in the sector is important from all points of view. It is good to familiarize yourself with research and development of drugs and monitor the news concerning the pharmaceutical industry, regulatory changes, and approvals by the competent authorities.