The career and scope in Drug Regulatory Affairs is vast and varied. It offers excellent opportunities for those who are passionate about this field and want to make a difference in improving public health standards. With the rapid advancement of science and technology, there are numerous opportunities available to those interested in this field. From research roles to regulatory affairs specialists, there are many roles available for those looking to pursue a career in Drug Regulatory Affairs.
Healthcare has been a part of our life since the evolution of mankind.
Treating the affected and making sure that each of us gets a chance of survival has been made possible only because of the research and progress done in the medical field.
Over the years, there has been a lot of advancement done in the healthcare field. Researchers are constantly experimenting to find solutions to uncured diseases and save lives. Many of them have even been successful.
In the past medical treatments devised to cure a particular disease or sickness raised the following questions like How do you know that these treatments actually work? How do you believe that there won’t be any side effects to these solutions? This is where the Regulatory affairs come to rescue.
There is no drug, medicine, or treatment developed that hasn’t been tried and tested by the regulatory affairs body. Drug Regulatory Affairs is formed by the government to ensure that public health is in safe hands and surveillance of the healthcare professionals.
Before we jump onto the facts let’s get a brief understanding of the basics!!
What Drug Regulatory Affairs Is Anyway?
If we think about monitoring a product for its safety and efficacy it seems easy but when observed closely it is quite the opposite. The Drug Regulatory Affairs committee is responsible to ensure that only the products that fall in regulation with the terms and conditions of public health are allowed in the market.
The Regulatory affairs domain is incorporated in almost every field of production and manufacturing be it food, medicines, medical equipment, technical devices, agrochemical, veterinary, etc. Every year, a large number of new products are developed by various pharmaceutical companies, all of which are then subjected to rigorous testing and verification procedures before the launch.
Every country has its own set of rules that needs to be fulfilled by the agencies. For India, all these standards are set by the CDSCO (Central Drugs Standard Control Organisation). The CDSCO is in charge of maintaining the efficacy and safety of different medical equipment and dosages.
Career And Scope In Drug Regulatory Affairs: Job Opportunities
Drug regulatory affairs is a diverse field with a lot of room for advancement.
As stated in a National Geographic article, “There are more viruses than stars in the universe,” this demonstrates how little we know about the universe and the creatures that inhabit it.
These viruses are the source of many deadly diseases that have been bestowed upon us, necessitating the development of a more robust and effective healthcare system.
All these statement make Drug Regulatory affairs a need for human survival.
Drug regulatory affairs is the domain in charge of testing and maintaining the safety of products in order to improve community health. Many important responsibilities fall to regulatory affairs professionals, such as monitoring research, data analysis, testing products for adverse effects, reviewing products in accordance with lawsuits filed in various countries, etc.
As the need for a more efficient healthcare system increases day by day it results to a rising demand for trained professionals in the field.
Demand Of Regulatory Affairs Professional In India
India is a diverse and developing country inhabiting a population of 1391.99 million people according to the statistics issued by Aaron O’Neill. Out of this large chunk of people, there are only 3.12 million active healthcare workers which is a very small number.
As the industries are evolving there is more need for a workforce in the regulatory affairs niche making it a promising and well-demanded career option. An investment in healthcare today can shape our country’s future.
The Government is constantly making efforts by investing more funds in this sector. A career in Drug Regulatory affairs can take you to unseen paths of success.
Roles And Responsibilities Of Regulatory Affairs Professional
The role of a regulatory affairs professional varies depending on their level of expertise. Working in the drug regulatory affairs department entails a variety of responsibilities, such as staying up to date on new regulations imposed by various countries, managing the testing process, making timely decisions, and so on.
A regulatory affairs graduate’s job title may be “Regulatory Affair Specialist” in most places, but the responsibilities are not limited to the job title. In the regulatory affairs field one day you can be a manager and the other day you can be a researcher, it’s that diverse.
Is Drug Regulatory Affairs The Right Career For You?
If you have an interest in managing things, an urge to know about the regulations of multi countries, would like the opportunity to engage and provide services to high ticket pharmaceutical companies from over the world then Drug Regulatory affairs is a great option for you.
In regulatory affairs, you have the liberty to switch up to different tasks and responsibilities. You’ll be serving your country and protecting lives by issuing effective medicines. If you want to make a change and are disciplined enough to work on your skills then Drug Regulatory Affairs could be a great investment into a global career.
Are You Eligible To Pursue A Career In Regulatory Affairs
Eligibility Criteria to pursue any course in Drug Regulatory Affairs be it a certificate course or a post-graduate diploma is:
- B.Sc/M.Sc in Life Sciences / Microbiology / Biotechnology / Zoology / Biochemistry / Chemistry / Nursing
- B.Pharm/ M.Pharm
- BAMS/ BHMS/ BDS/ MBBS/ Physiotherapy.
Core Skills of A Regulatory Affairs Professional
The amount of dedication and hard work you put into upgrading yourself is going to determine your point of success. The Core skills to succeed in Drug Regulatory Affairs are:
- Consistency
- Quick Learner
- Exploring Mindset
- Leadership
- Communication
- Accurate Decision-Making
- Problem-Solving
- Keeping up with the rules and regualtions
Current Trends In Drug Regulatory Affairs
AI And Machine Learning
Since the introduction of technology, we have seen the automation of things in every aspect of life. Many innovative technical equipment, such as health monitoring devices, AI-assisted surgeries, online doctor consultations, data-based medical treatments, and so on, have been implemented. With an increase in Innovation and AI in healthcare, the scope to surveil the effects and usability of these devices has become a need so it does not turn out to be a disaster. All these factors contribute to increasing the demand and importance of Drug Regulatory Affairs in the near future.
Virtual Trials
With the technological advancements being done in the healthcare niche there’s soon gonna come a time when even the clinical trials will be conducted online. It will be as simple as asking a friend for assistance with a project. As these new models of research are developed, regulatory affairs is playing a vital part to set the guidelines and monitor the patient rights being granted through the trials.
Mobile Apps
Since the takeover of social media, the awareness about health care has increased and people have started to be more considerate of their well-being. Healthcare when merged with technology provides a miraculous solution. One of which is the healthcare mobile apps that can be leveraged to achieve our healthcare solution goals along with efficiency and quality. The mobile apps developed for this purpose must be tried and tested effectively to identify the loopholes and key points which bring the regulatory affairs into the picture.
Future Trends
Augmented Reality
The next big thing that’s gonna change the healthcare domain is Augmented Reality. Imagine conducting surgeries without any patient, sounds stupid right? But this unrealistic thought here has the potential of becoming the future trend. There will be a time in the future when all complex surgeries will be performed using AR, without causing any harm and errors at the time of complex surgeries.
The Internet of Medical Things (IoMT)
Working from home and not being bound by geography has become the new normal. Healthcare is following the suit and going remote as well. Patients will no longer need to go to the hospital for treatment because IoMT will allow them to be cured remotely. IoMT is bridging the gap between healthcare and the rest of the world in ways we never anticipated. Doctors can use IoMT to maintain track of patient data via mhealth devices, generate patient progress reports, and study potential treatments for diseases.
Conclusion
As we have gone through all the new upgrades that are ready to dive into the healthcare pool we can say that Drug Regulatory Affairs is going to be mandatory on the checklist for milennials.
All the new methodologies, devices, treatments, mhealth applications, etc will need to be handled and experimented by an authorized body. Without regulatory affairs, all these developments cannot access the global market, which is quite obvious because it’s the well-being of all the humans we are talking about.
The Regulatory Affairs Committee will assist in determining the benefits and drawbacks of a product, testing it, and launching it only if it can bring value and comfort to our daily lives. If you wish to work in regulatory affairs, this is a fantastic moment to do so because the field is still evolving and many developments require monitoring and oversight.
