Regulatory Affairs

A lot of my friends from college and people who have recently met me often ask about my job profile and try to understand what I do and how i got into it. As a matter of fact, I had studied clinical pharmacy and not industrial pharmacy. However, the placements in the colleges can play a huge role in determining what career path you may take and it can give some degree of assurance and confidence to take a leap of faith.

For me it was Regulatory Affairs. I had often heard about it and not really studied much regulatory science , but we had a subject in 5th year Pharm.D called Clinical Research, while it was aimed at understanding drug discovery, but it was more of regulations.

To begin with there are two major health authorities which practically determines the outcome of a novel drug discovery , generic drugs, or management of established products,  EMA ( European Medicine Agency and FDA ( Food and Drug Administration). The two HA’s basically guide the companies how they can handle the life cycle of a drug. During the process, an HA has different regulatory pathways, these are means or roads to submit a change happening in the already established drug or they can be a path to submit a molecule for approvals. For example- EMA has variations , like Type IA, Type II, Type IB, these are used on the basis of how significant the impact of a change is. Similarly FDA has CBE 30, or 501(K) application for devices. The whole of regulatory science mostly revolves around these.

As a discipline RA covers a broad skill set and sub domains. It is composed of group of people who act as a liaison between potentially conflicting worlds of government, industry and consumers to help the products stay safe and effective. It is the responsibility of an RA professional to stay updated with latest guidelines, legislation, and intelligence. Most companies assess and prioritize new projects based on intended target product profile, the RA professional plays a key role in advising on what will be the better way of prescribing the labels, and how to keep the changes in control.

There are two major departments through which other streams bifurcate :-

CMC (Chemistry Manufacture and Control) is a domain where a person has to understand the non clinical part, like shelf life, site release, cell banks, or stability controls, manufacturing site transfers. Its a core field where a medical professional can work and will enjoy it.

RA Therapeutic Area handles clinical aspects, which can have risk management plans, periodic safety update reports, promotional materials, labeling tasks. To explain each and every task is out of scope for the current post, but in the future posts we will try and explain a lot of different topics.

Both the above mentioned roles have regulatory publishing ingrained into them. A person will have to publish documents related to either CMC or RA clinical part for maintaining the life cycle of the product. While regulatory publishing does not review the documents or handles labeling , it is an operational task which is very crucial. It uses tools to publish the documents in the CTD triangle format (image below) in a very systematic manner. One should have a flair of IT systems and should be innovative in finding out new ways of improving the existing processes. I had started my career through Regulatory publishing, it was a good experience.

The RA department also reviews all documentations from a regulatory perspective, ensuring that it is clear, consistent, and complete and that its conclusions are well defined. As a clinician an RA professional will have to deal with the drug CTD which is according to the ICH guidelines arranged into five modules and coordination with various stake holders in different departments of a company.

It can be any of the 5 modules of the CTD traingle which will need a submission to HA. It can also be a clinical trial study report, or it can be a response document for a health authority . The changes happening to an established or an old drug product can be from any of the modules present in the triangle and it forms the backbone of drug submissions.

An RA professional is expected to be updated with guidelines and rules for better understanding of the processes and submission involved.

Regulatory Affairs is a challenging field which demands inventing yourself every day for new tasks and activities. One should be committed and determined and see the tasks through the end. The health authorities around the world are changing rules and guidelines quite frequently while this may not be a good thing, but for the patients such changes are needed if one needs to balance the risks and benefits.


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