What is Regulatory Affairs?
The science responsible for applying the standards and regulations that assess the safety, efficacy, quality, and performance of the regulated medical products in order to get regulatory authorities’ approvals. Regulatory affairs is the link and the “go-between” the pharmaceutical or medical device company AND the regulatory authority that regulate them like the U.S. Food and Drug Administration, European Medicines Agency, or any equivalent authority. The biomedical industry needs regulatory affairs specialists to help engineers and scientists meet the regulatory authorities’ standards as they develop new drugs, medical devices, and biologics.
What Do Regulatory Affairs Specialists Do?
- Advise engineers, scientists or project teams about regulations and standards.
- Compliance with domestic or international regulatory agencies and inspectors.
- Prepare, gather, and review raw documents, including reports, international standards, harmonized guidelines, and clinical protocols.
- Prepare or review regulatory submissions.
Innovation is rife in today's world, but there is a long path from concept to implementation.
Almost every stage in the lifecycle of drugs and medical devices, from R&D through clinical research to marketing, is subject to regulatory oversight.
The development of new drugs, biologics, and medical devices constitutes a lengthy, intricate, and costly endeavor. It’s estimated that creating a new drug can span up to 15 years and incur costs of up to $2 billion. Consequently, the pharmaceutical industry faces immense pressure to streamline the time and expenses associated with bringing these products to market.
The success of a pharmaceutical company increasingly relies on professionals with expertise in regulatory processes, given the continuous updates in legislation, policies, and technologies.
Considering the vast array of products regulated by authorities, it’s evident why professionals versed in Regulatory Affairs are more crucial than ever.
There are numerous avenues within the field of Regulatory Affairs, including collaborating with government organizations to safeguard patient safety or aiding companies in launching compliant medical products into the market.