Regulatory affairs

Regulatory Affairs is the real safeguard of the pharmaceutical industry.

What is regulatory affairs?

It can take 10-12 years for a medicine to progress through the entire development process, from laboratory to clinic. Throughout this process, and even after a new medicine reaches the market, there are huge amounts of legislation in place to ensure the treatment is as safe and efficacious as possible. Regulatory affairs, as its name suggests, encompasses all of the regulatory protocols surrounding a medicines development, and ensures these are adhered to at each stage of development.

Before a medicine can be released to the UK market, it must be granted a Product License, or Marketing Authorisation, by the Medicines and Healthcare Regulatory Agency (MHRA). Alternatively, the European Medicines Agency (EMA) will grant a license for marketing across the entire EU. Those working in regulatory affairs ensure the new medicine has undergone the appropriate testing requirements, with proper analysis of test results, and relay this information to the correct regulatory authority.

Once a new medicine has been licensed for marketing, its packaging and supporting information must be medically accurate and comply with its Product License. The medicine must also be continually monitored in the real world to detect any rare adverse reactions, and obtain additional data about how the medicine performs. Therefore, regulation of a medicine continues well after it has been approved for marketing.

A career in regulatory affairs

In order to obtain a Product License professionals working in regulatory affairs must keep track of the ever-changing legislation around drug development processes, and ensure the correct procedures are followed. This requires coordinating with many teams across all stages of development, such as research and development groups, clinical trial groups and legal teams, which means working with people from a huge variety of backgrounds. Depending on the country a medicine is to be marketed in, regulatory affairs professionals will need to keep up-to-date with the different legislation for various countries, and adhere to their requirements. Once a product has been licensed for marketing, the next step is to coordinate with physicians in medical affairs to ensure the promotional material for that medicine is medically accurate, and in line with its Product License.

Working in regulatory affairs can therefore be fast-paced and high pressure, due to the regulatory landscape continually changing. However, it also provides a holistic view of a medicine's development, and the opportunity to work with a diverse group of professionals. Regulatory affairs may also be a rewarding career – as the work helps ensure safe medicines are produced, and focuses on patient well-being.

Qualifications and training

A Life Sciences degree is essential for a career in regulatory affairs, as the work requires an understanding of the science behind developing a medicine, and the ability to communicate this knowledge to various audiences.

To enter the regulatory affairs profession, a graduate may have to hold another role within the pharmaceutical industry, prior to their first regulatory affairs role. This is due to the fact there are few work experience opportunities within regulatory affairs, although some consulting companies may have in house training courses. However, there is a benefit to working within industry; these roles provide additional knowledge and understanding of the drug development process, which is essential in regulatory affairs. Thus, initial industry roles are a useful foundation for those looking to enter regulatory affairs.

The Organisation for Professionals in Regulatory Affairs (TOPRA) has post-graduate qualifications available in partnership with universities, which may be an alternative option for those wishing to specialise in regulatory affairs. For those currently at university studying life sciences, TOPRA's Careers Fair may provide additional information and opportunities relating to regulatory affairs. Also useful for university students are Industrial research placements, which many courses now offer as sandwich years. Read an example of a regulatory affairs industrial placement.

TOPRA also has a useful Careers site for those wishing to learn more about regulatory affairs, the site includes links to case studies from regulatory affairs professionals.