Understanding Pharmaceutical Regulatory Affairs


November 8, 2023

The journey from a laboratory discovery to a market-ready medicine is a lengthy one, spanning 10 to 12 years. Throughout this intricate process and even beyond a drug’s market release, a web of regulations is meticulously woven to ensure utmost safety and effectiveness. Regulatory affairs, as the name implies, encompasses the entirety of these regulatory procedures throughout a medicine’s development, diligently ensuring compliance at every stage.

In the United Kingdom, before a medicine can make its way to the market, it must secure a Product License or Marketing Authorisation from the Medicines and Healthcare Regulatory Agency (MHRA). Alternatively, the European Medicines Agency (EMA) grants marketing licences covering the entire EU. Professionals in regulatory affairs play a pivotal role in ensuring that the new medicine has undergone rigorous testing, with comprehensive analysis of test results, and that this critical information is appropriately conveyed to the relevant regulatory body.

Post-marketing approval, the medicine’s packaging and supporting information must maintain medical accuracy and align with its Product Licence. Continuous real-world monitoring is essential to detect any rare adverse reactions and gather additional data on its performance. Consequently, the regulation of a medicine extends well beyond its initial approval.

A Career in Regulatory Affairs

To secure a Product Licence, regulatory affairs professionals must vigilantly track the ever-evolving landscape of drug development regulations and ensure strict adherence to correct procedures. This entails seamless coordination with multidisciplinary teams spanning various developmental stages, including research and development, clinical trials, and legal teams. Regulatory affairs professionals must also remain well-versed in diverse sets of legislations for different countries, based on where the medicine is to be marketed. After obtaining marketing approval, collaboration with medical affairs physicians becomes crucial to ensure the medicine’s promotional materials are not only medically accurate but also in line with its Product Licence.

A career in regulatory affairs can be fast-paced and demanding due to the continuously shifting regulatory environment. However, it offers a comprehensive perspective on a medicine’s development and the opportunity to collaborate with professionals from various backgrounds. Moreover, it can be a highly rewarding profession, as the work directly contributes to the production of safe medicines and focuses on patient well-being.

Qualifications and Training

A background in Life Sciences is imperative for a career in regulatory affairs, as it necessitates a profound understanding of the science underpinning drug development and effective communication of this knowledge to diverse audiences.

To enter the regulatory affairs field, graduates may need to first hold another position within the pharmaceutical industry. This is because work experience opportunities within regulatory affairs are limited, although some consulting firms may offer in-house training courses. However, working within the industry provides valuable insights and comprehension of the drug development process, serving as a solid foundation for those aspiring to enter regulatory affairs.

At Avery Fairbank, we deeply appreciate the significance of regulatory affairs professionals in safeguarding pharmaceutical safety and efficacy. Our seasoned team excels in identifying top talent within this field, ensuring your organisation’s commitment to compliance and effectiveness. Whether you are looking to strengthen your regulatory affairs team or seeking expert guidance, we invite you to explore our website for more information about our executive search services, or get in touch to discuss your unique requirements.

Pharma Regulatory Affairs

Published on 08-11-2023