Everything you need to know about
Regulatory Affairs
Since the field of pharmaceutical drug development, manufacturing, and marketing has been governed by regulatory agencies such as the US FDA, EMEA, MHRA, and others, the field of Regulatory Affairs has opened up new employment opportunities. The expansion of the clinical research industry has increased the demand for skilled regulatory affairs professionals. Read here to know what is regulatory affairs.
Pursuing a career in Regulatory Affairs in clinical research can prove to be quite rewarding and exciting because the regulatory function is critical in ensuring that safe and effective healthcare products are available globally.
What is Regulatory affairs?
Regulatory affairs encompasses a wide range of specialized skills and occupations. In the best-case scenario, it is made up of a group of people who act as a bridge between the potentially antagonistic worlds of government, industry, and consumers to ensure that marketed products are safe as well as effective when used as directed.
What is Regulatory Affairs in clinical research?
Regulatory affairs (RA) in clinical research refers to the regulatory body in a pharmaceutical company. This department is in charge of acquiring approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wishes to keep the product on the market. It acts as a liaison between the regulatory authority and the project team, as well as a channel of communication with the regulatory authority as the project progresses, with the goal of ensuring that the project plan accurately anticipates what the regulatory authority will require before approving the product.
It is the responsibility of RA to stay current on legislation, guidelines, and other regulatory information for the discovery, testing, manufacture, and marketing of these products to ensure that they supply safe and worthwhile products.
What do RA professionals do?
The following points encompass the responsibilities of an RA professional:
- Keeping up with the ever-changing legislation in all countries where a company wants to sell its products
- Providing guidance on legal and scientific constraints and requirements
- Scientific data collection, compilation, and analysis
- submitting registration documents to regulatory agencies and conducting any subsequent negotiations required to obtain or maintain marketing authorization for the products under consideration
- Rendering strategic and technical advice at the highest levels of their companies
- Making a significant commercial and scientific contribution that can lead to the success of a development program and the overall company.
What are the competencies and skills required for becoming an RA professional?
An RA professional must possess the following set of skills:
- Out-an-out understanding of the drug development process, as well as a solid understanding of ICH-GCP.
- Comprehensive and strong command of writing skills and spoken English
- Confidence
- Multi-tasking ability
- Self-motivation and the ability to work independently
- Strong customer focus
- Knowledge of basic word and data processing software such as MS Word and Excel
What qualifications do you require to pursue a career in RA?
A degree in Life Sciences is required for a career in regulatory affairs because the work requires an understanding of the science behind developing medicine as well as the ability to communicate this knowledge to a variety of audiences.
A graduate degree may be required to hold another role within the pharmaceutical industry prior to their first regulatory affairs role in order to enter the regulatory affairs profession. This is because there are few opportunities for work experience in regulatory affairs, though some consulting firms may have in-house training courses.
However, there is an advantage to working in the industry; these positions provide additional knowledge and understanding of the drug development process, which is necessary in regulatory affairs. Thus, initial industry roles provide a solid foundation for all aspirants seeking a career in regulatory affairs.
Looking to explore a career in regulatory affairs?
Lifepoint Research LLP provides comprehensive and up-to-date courses on the global regulatory landscape. It walks you through updated guidelines from the world’s major regulatory agencies. We offer to provide candidates with knowledge and practical information about the industry, working modalities, trial methodologies, drug development safety and legality, post-marketing safety checks, and all other important aspects.
Contact us for more information!
