How Freshers/Students can master themselves to enter in the field of Regulatory Affairs!

Today, with my first original individual article, I want to address and dedicate this article to the young talents like me who are seeking to enter the world of regulatory affairs or people who are looking for a field switch and want to enter into regulatory affairs.

First things first!!! Please note that this article is to be read as my opinion from my own experience. This should not be considered as the only way to enter the regulatory world. These are just a few tips to master yourself for entering into the domain of the regulatory affairs.

Education:

For entering into the field of Regulatory Affairs, you need a minimum degree in a relevant scientific field. Majority of people who enter into regulatory affairs are from backgrounds with B.Sc., M.Sc., B.Pharm, M.Pharm or a PG Diploma in Regulatory Affairs. You need to have these minimum requirements, if you want to enter into the regulatory world.

Apart form this, I would recommend it would be a plus if you have a one or two certifications on regulatory affairs or related skills. This really helps if your course is from a reputed learning platform like Coursera, Udemy, LinkedIn Learning, etc.

Knowledge:

As a fresher, none of the company will expect you to know everything! But you need to make sure, you know the basics! And by basics, I don't mean simply the definition of REGULATORY AFFAIRS! It might sound funny, but I've literally seen people just mugging up the definition of regulatory affairs and considering it as the only prep for their interview. This doesn't really helps.

By basics of regulatory affairs, I mean to say:

You need to make your concepts clear on key regulatory terms. You need to understand how different regulated markets are governed by separate regulatory authorities. You need to make sure you know how to surf on to reach the web pages of regulatory authorities of specific country. Yes, this sounds easier but trust me it is indeed the most difficult part. The websites of regulatory authorities are mindfully crafted and has immense of data for us to be read. You as a key regulatory enthusiast, should have the ability to navigate through different sections available on the website.

Apart from this, you also need to keep your grasping game high! I know those repetitive lines and big paragraphs are sometimes too uninteresting to read; but there is no escape from it. You HAVE to HAVE the strength to read and grasp it as early as possible. It's absolutely fine, if you cannot understand specific terms and requirements. At such times, you need to make sure you stop, ask for help from your seniors or some colleague who is already in the field and make your concepts clear.

Skills:

This is the most important part of my article and I hope you continued your reading and must have reached till this part.

In my opinion and in my 2 and a half (2.5) years of work experience in Regulatory Affairs, and by my general observation I would like to list down key skills that are a must for a fresher to enter into the regulatory affairs domain.

Here are few must-have key skills that every fresher who wants to enter the world of Regulatory Affairs :

1. Knowledge of using Internet for Regulatory purpose

You should know the basics of operating on Internet and be able to precisely surf on the websites of the regulatory authorities. You should be able to quickly surf and find specific guidelines, guidance documents and several notices and alerts that are published in public interest on websites of regulatory bodies. You should be a pro at being able to find product-specific, country-specific and submission-specific guidelines that are publicly available on the websites.

2. Basic Knowledge of several regulatory documents

You should be able to search and read several important regulatory documents like FDA Guidelines on Drug/Drug Products, EMA Guidelines on Drugs, Biologics, etc., the ICH Guidelines (Quality, Safety, Efficacy & Multidisciplinary) and other key guidance documents which are available on the website of regulatory bodies. Basically, you should be able to crack your interview showing off your clarity on basics of such guidance documents.

3. Knowledge of key regulatory terminologies

You should have a hold on the usage and meaning of several important terminologies that are used most often in regulatory environment. A few examples are terms like "Quality", "Compliance", "Adhere", "Comply", "Non-conformance", "Quality Assurance", "Quality Control", "Stability", "Recall", "Adverse Effects", "Observation", "Non-Compliance", "Action Plan", "CAPA', "ANDA", etc. The list is non-exhaustive; this is just an example of few words that you should be aware of.

4. Good Verbal and Written Communication Skills

You need to develop your communication skills because the more competent you are at this skill, the more likely are your chances to quickly get on board with full fledged regulatory projects. You need to have a better understanding on proper usage of grammar and how you need to be very picky and very careful while drafting any information. Thanks to AI platforms like ChatGPT for those who are not proficient at using the English for professional communications, but if you are good at English, I personally prefer to develop this skill on your own rather than depending on such AI platforms, because many times AI can completely change what you want to convey and this can end up in ways that you did not expect. So better to learn and get along with communicating in English as soon as possible.

5. Attention to Detail

The most important skill that any regulatory professional must have is the attention to detail. There are several lengthy document when you need to plan your regulatory submission. As a regulatory person, it becomes your responsibility to carefully examine each and every sentence and make sure nothing is left unread. You need to point-out even the minutest of mistake or human error and report it before submissions. Because in regulatory world, even the smallest of mistakes can create big blunders and can be costly to the company later.

6. High degree of interpretability

As a regulatory professional, you must have the power to interpret. Here, you need to be a pro at understanding the key requirements of a guideline and you should develop a practice of being able to interpret the meaning of it and put it into practice in the manufacturing area and/or other zones of the company.

7. Quality of being vigilant

Being a strict eye on the continuous supply of products also is a part of work for a regulatory professional. As a fresher, I suggest you to keep surfing about the supply chain of pharma, medical devices, biologics, vaccines and keep a track on the notices and recalls of such products that are issued in public interest. This helps you to keep a track of the trend of recalls and notices and keeps you aware of such events.

8. Quality of being keeping up-to-date

This is the most important skill if you want to pursue your career in the field of regulatory affairs! You need to keep yourself highly updated on the ever-changing norms, guidelines and rules and regulations. The regulatory world is ever changing and as a regulatory professional, it becomes your duty to know the updates and keep your compliances in line with the new requirements in the updated guidelines and regulations.

9. Good drafting skills

You need to have a hand on drafting documents. You should be able to write scientifically sound, logical, reasonable and smartly curated technical documents. Because this is where you can shine! This is the most crucial part where majority of regulatory professionals lag and they end up getting non-compliance and observations during audits. You need to play smart and keep your writing game top-notch! This is the only way how you can stand apart from other crowd! So better start being a pro at writing from the beginning.

10. Good public speaking skills

I know this might make you wonder why this skill. But trust me, you need to have the confidence to address a bunch of people! Regulatory Affairs have the main job responsibility to face regulatory audits. And here, facing audits simply doesnt mean representing your Dossiers and Reports. Here, you need to answer most of the crucial and tricky questions which can save you from getting non-compliance or observations from the regulatory authority. You may not be a part of the audit for a few years, even I have not faced any audit yet, but you need to make sure you have that confidence. And this confidence can only come by practicing public speaking and having group discussions with your colleagues on such important topics.

Note: This article intends to educate the job-seekers, freshers and students who want to enter the field of regulatory affairs. Please take away the tips from this article as an opinion/perspective from my side. I have shared these tips on the basis of my personal journey, my education background and as per my experience in this field. Please understand and be mindful that other experienced people can have different opinions than mine, too. I do not intend to present this article as the only means to enter the field of regulatory affairs. It is possible that I might have not mentioned all the points, but you can always find what you want from ample of information available on the internet.

Hope these tips help you to enter the field of regulatory affairs.

For any such tips and for one-to-one discussions, feel free to drop me a message on my LinkedIn Veer Patel .