The pharmaceutical industry is one of the most regulated industries there is. Consequently every aspect of the research and development of new medicines is regulated. The individuals who navigate those regulations are called Regulatory Affairs professionals.

I remember when I told a pharmacist colleague that I was going to become a Regulatory Professional, he said something that implied I was going to be shuffling papers. Little did he know how important the Regulatory Affairs professional is. As a Pharmacist, he would be able to impact thousands of patients, but a Regulatory professional can impact millions of patients because of the importance of their work. He would dispense and advise patients how to take medicines, but the Regulatory professional designs how the drugs are researched and developed. There is no comparison in terms of the numbers of people who can be impacted.

The Regulatory Affairs professional, is a vital part of the project team. If they are not good at what they do, other people lose their jobs. If they are good at what they do, the company thrives. Regulatory experts must have a thorough understanding of many areas of science, as well as the regulations. It is exciting, but also daunting. So yes, there are the regulatory professionals who shuffle papers, and then there are others who are extremely sought after for advice and direction. They usually have higher degrees, and truly understand the science that they are overseeing.

The other speciality in regulatory affairs is Operational Regulatory Affairs. These professionals may not have higher degrees, but may be competent at compiling applications and submissions. They may have expertise in the digital sciences, such as electronic submissions. They are always going to be overseen by the higher level regulatory professionals, who are strategic, and yet understand operations.

When looking for help, many smaller biotech companies hire the operational regulatory affairs professionals. They do not understand strategy, and so often the programs they are overseeing run into significant problems that they cannot address. Their fees may be lower than expert regulatory strategists, but you know what they say about paying peanuts!

Operational regulatory affairs consulting is not Strategic Regulatory Affairs. The latter develop regulatory strategies to meet the needs and requirements of the programs they are working on. Hence, strategic regulatory affairs consulting is a specialized service offered by Regulatory Experts who implement and develop new regulatory strategies.

Regulatory strategists identify the potential risks and develop regulatory strategies and plans to navigate them. In Global Regulatory Affairs consulting we keep the clients up to date regarding changes in global regulations. We provide strategic guidance to pharmaceutical companies and navigates regulatory challenges. We also optimize processes.

Now you know more about the different types of regulatory professionals, why not get in touch to see if we can help you address any of the following challenges:

• Development of regulatory strategies
• New drug approvals
• Differences between regulatory authorities and how to navigate them
• Other areas of concern

Speid & Associates Expert Consultants provide up-to-date information to their clients regarding emerging trends and regulatory changes related to companies. We look forward to hearing from you.