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 jobs can be found across the following specialist areas:

  • UK Regulatory Affairs
  • EU Regulatory Affairs
  • International/Global Regulatory Affairs
  • Emerging Markets Regulatory Affairs
  • Regulatory Operations
  • Regulatory CMC
  • Regulatory Artwork/Labelling

Here are some examples of regulatory affairs jobs at different levels:

  • Regulatory Affairs Assistant
  • Regulatory Affairs Officer / Executive / Associate
  • Regulatory Affairs Senior Officer / Senior Executive / Senior Associate
  • Regulatory Affairs Specialist
  • Regulatory Affairs Project Manager
  • Regulatory Affairs Manager / Senior Manager
  • Regulatory Affairs Associate Director/Director
  • Regulatory Affairs Vice-President
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).