Compared to other areas of the pharmaceutical sector, regulatory affairs is a relatively new profession. It has come from the need for companies to ensure the safety and effectiveness of their products for patients and consumers worldwide. Regulatory affairs is applicable to pharmaceuticals, medical devices, biologics and functional foods.
What is Regulatory Affairs?
Regulatory affairs combines a unique mix of scientific, legal and corporate awareness to make sure that products are developed and manufactured in line with industry and government standards. Regulatory affairs professionals work hard to do this by ensuring the necessary licensing, marketing and legal components are all compliant before the product is allowed to enter the marketplace.
A company’s regulatory affairs department can be involved in all steps of the drug development lifecycle, from the early non-clinical studies through to development, as well as the manufacture and marketing stages.
Regulatory affairs professionals form a vital bridge between their company and the regulatory agencies. These agencies include:
Regulatory affairs professionals can be found across the following specialist areas:
UK Regulatory Affairs
EU Regulatory Affairs
International/Global Regulatory Affairs
Emerging Markets Regulatory Affairs
Here are some examples of regulatory affairs roles at different levels:
Regulatory affairs (sometimes abbreviated to RA) refers to a field of expertise that can be found in regulated industries such as medical devices and pharma. It covers everything an organisation might do to ensure that they are complying with all relevant legislation and industry regulations.
Much of RA is concerned with the so-called ‘regulatory climate’ around specific issues – for instance, a regulatory affairs professional working for a pharmaceutical company might have to assess the ‘regulatory climate’ surrounding the promotion of over-the-counter medication.
What does a regulatory affairs officer do?
Essentially, the job of a regulatory affairs officer is to ensure that their organisation is fully compliant with all applicable laws and regulations. The role may involve a lot of meetings and travelling around, since an RA officer will frequently act as an intermediary between their employer and the relevant regulatory authorities.
Why work in regulatory affairs?
A career in regulatory affairs can be highly rewarding. Benefits include:
Salaries ranging from £20,000 (entry level) to £100,000 for the most senior positions
Plenty of opportunities for growth and career advancement
Option to work as a consultant once experienced
An ideal profession for people who like to travel
Regulatory affairs is a niche field for which Hyper Recruitment Solutions (HRS) is a specialist recruiter. We list a variety of regulatory affairs jobs through our website, and we spend a lot of time networking with regulatory affairs professionals all over the world to ensure that we are up to date with the latest changes in regulatory legislation. Many of the regulatory affairs personnel we speak to are members of The Organisation for Professionals in Regulatory Affairs (TOPRA).