Healthcare is no longer limited to just hospitals and consultations. The pharmaceutical, biotechnology, medical device, and healthcare industries are growing and need professionals to help take products and services through the regulatory process before they reach the target audience. This is where regulatoryaffairs comes in.
MBBS and BDS graduates are looking to expand their horizon beyond traditional roles and regulatory affairs is one such area. It offers a blend of healthcare, science, documentation, and compliance without requiring professionals to spend their entire working day in a clinical setting.
Let’s start by understanding what regulatory affairs is and whether it fits your background and interests.
What Is Regulatory Affairs?
Regulatory affairs is a healthcare industry function that oversees the compliance of different products and services with applicable laws and regulations.
Regulatory affairs (RA) professional works as a bridge between a company and regulatory bodies. Their responsibilities can range from preparing submissions and reviews to tracking and analyzing regulations.
The work of RA includes preparing regulatory submissions and documents, maintaining records, product registration and approval, remaining compliant with evolving rules, understanding scientific and technical aspects of products, and other similar activities.
Depending on the organization, RA professionals address the needs of different markets (US, EU, UK, Australia, Canada, etc.).
While the role is largely paperwork-oriented, it requires a good understanding of the scientific and technical aspects of the products and the expectations of the regulatory bodies.
Healthcare professionals can be a great fit for this role since they have an inherent understanding of the medical and scientific aspects of the products.
Why MBBS Graduates Should Think About Regulatory Affairs ?
An MBBS graduate has spent a considerable amount of time studying medicine, pharmacology, pathology, clinical trials, and related subjects. While some may want to pursue a clinical specialization, others may not wish to continue their studies due to the excessive time and effort required.
For these graduates, regulatory affairs can be a suitable alternative career option that allows them to remain in the healthcare industry without spending years in residency or a specialist course.
Careers in regulatory affairs can be ideal for MBBS graduates who want to:
- Limit direct patient interaction
- Avoid long-hour shifts
- Work in a pharmaceutical, biotechnology, or healthcare organization
- Pursue international opportunities
- Remain in the healthcare sector while working in a corporate environment
- Work on medical products and documents
- Transition into a healthcare-related compliance or regulatory career
Regulatory affairs jobs for MBBS graduates can be a good fit since they offer the opportunity to apply one’s medical expertise and knowledge of medicine, pharmacology, and related fields. This can be significantly more valuable than an engineering or business graduate who has little understanding of the medical utility and technical aspects of a drug or healthcare product.
Medical graduates who complete a regulatory affairs course and acquire the required expertise can expect to have a competitive edge over non-medical professionals in the RA job market.
The clinical knowledge acquired in an MBBS course enables one to understand drug indications and contraindications, clinical trials, and medical treatment and disease areas. Such insight can be critical when it comes to evaluating the technical and scientific aspects of a drug or a medical device.
As a result, regulatory affairs can be an ideal career option for MBBS doctors who enjoy the science and research aspect of medicine but do not wish to pursue clinical specializations.
Regulatory Affairs Jobs For MBBS Graduates
There are several regulatory and related job opportunities for MBBS graduates in the pharmaceutical and healthcare sectors.
Some of the common roles that MBBS doctors can consider include the following:
Regulatory Affairs Associate
Regulatory affairs associates handle a variety of tasks, from preparing regulatory submissions and documents to product registration and maintaining compliance with the evolving regulations.
They may also perform other duties, including preparing and maintaining regulatory records and submissions, product registration, monitoring and compliance, technical and scientific product analyses, and similar tasks.
This is one of the most common entry-level regulatory affairs jobs for MBBS doctors.
Regulatory Medical Writer
Regulatory medical writing is one of the most common career options for MBBS doctors in the regulatory affairs space. This is primarily because of the significant overlap between the two specializations.
Regulatory medical writers typically handle clinical study reports, technical and scientific documents, and various other regulatory submissions. As a result, MBBS doctors with excellent writing and communication skills can consider a career as a regulatory medical writer.
Clinical Research and Regulatory Associate
There is a significant demand for clinical research associates and regulatory affairs associates in the clinical research organization (CRO) space. The CRO industry offers a wide range of job opportunities for MBBS doctors, spanning from clinical trial management to regulatory affairs.
A career in clinical research and regulatory affairs can be ideal for MBBS doctors who want to remain in the healthcare sector while limiting direct patient interaction.
Drug Safety and Regulatory Associate
Pharmacovigilance and regulatory affairs are closely linked, primarily since drug safety data is often submitted to regulatory bodies as part of the product approval and lifecycle management.
As a result, MBBS doctors who are interested in the safety aspect of drugs and medical devices may want to consider a career in pharmacovigilance and regulatory affairs.
Regulatory Intelligence Associate
Regulatory intelligence associates typically perform a combination of regulatory research and preparation of technical documents. They stay updated about the evolving regulations and ensure that the company is aware of the changes.
As a result, regulatory intelligence can be a good fit for MBBS doctors who are interested in the research aspect of regulatory affairs.
This is by no means an exhaustive list of job opportunities for MBBS graduates in the regulatory affairs space. The above-mentioned roles are some of the most common ones that medical graduates can explore.
| Qualification | Typical Experience | Predicted CTC in India* |
| MBBS | Fresher | Around 10 LPA |
| 2–4 years | ₹10 to 12 LPA | |
| 5-8 years | ₹12 to 16 LPA | |
| >10 years | ₹16 to 24 LPA | |
| BDS | Fresher | ₹3-6.5 LPA |
| 2-4 years | ₹4-7 LPA | |
| >5 years | ₹ 5-8 LPA |
Can BDS Graduates Get Into Regulatory Affairs?
Absolutely.
BDS graduates are not restricted to clinical dentistry. A similar logic applies to BDS graduates as well, except that they have an even more compelling case for a career in regulatory affairs.
There are a number of reasons why regulatory affairs jobs for BDS graduates can be a good fit, including the following:
- The majority of regulatory affairs roles, particularly in the medical device space, do not require direct patient interaction.
- Many regulatory affairs roles for dental professionals involve a combination of clinical and regulatory affairs expertise.
- The dental specialization provides a significant advantage when it comes to medical device regulatory affairs, particularly in the implantable, orthodontic, diagnostic, and other related devices.
- A career in regulatory affairs can be highly rewarding for dental graduates who have an interest in the science and research aspect of the field.
BDS graduates can explore many of the same job opportunities as MBBS graduates, although dental product regulatory affairs, medical device regulatory affairs, and related fields would be their primary areas of interest.
Some of the common job opportunities for BDS graduates in regulatory affairs include the following:
- Regulatory affairs associate
- Medical device regulatory associate
- Regulatory medical writer
- Clinical research associate
- Pharmacovigilance associate
- Regulatory documentation specialist
- Quality and compliance associate
- Medical affairs associate
The eligibility criteria for these roles can vary significantly, and it is always a good idea to review the requirements before applying. This is by no means an extensive list of job opportunities for BDS graduates. The above-mentioned roles are some of the most common ones that dental doctors can consider.
Companies Hiring for Regulatory Affairs Roles
Many opportunities exist across pharma, CROs, biotechnology and medical-device companies.
Masimo, for example, hires for the position of regulatory affairs specialist, where professionals may support international regulatory filings, maintain regulatory documentation, and handle regulatory activities related to the Indian market.
Accenture offers roles such as life sciences regulatory services associate, which may involve document formatting, quality checking, working with research and development data, and supporting compliance-related activities.
Similarly, Genpact offers positions such as regulatory affairs operations specialist, where responsibilities may include supporting internal reporting, collecting and validating data, maintaining report accuracy, and assisting with technical and regulatory requirements.
MBBS Vs BDS: Which One Has An Advantage?
The strengths of the two qualifications are different, and the choice between the two will depend on a person’s strengths and career interests. A comparison of the strengths of MBBS and BDS graduates in the context of regulatory affairs is presented below.
| Area | MBBS Graduate | BDS Graduate |
| Clinical medicine | Strong | Moderate |
| Pharmacology knowledge | Strong | Good |
| Anatomy and pathology | Strong | Strong |
| Dental product knowledge | Limited | Strong |
| Medical device opportunities | Good | Good, especially dental devices |
| Clinical research | Strong | Good |
| Medical writing | Strong | Good |
| Drug regulatory affairs | Strong potential | Strong potential |
| Dental/orthodontic devices | Moderate | Strong potential |
| Regulatory documentation | Requires additional training | Requires additional training |
What Are The Skills Required For Regulatory Affairs?
A degree in medicine or dentistry is not a sufficient skill set for a career in regulatory affairs. As a result, MBBS or BDS graduates who are interested in the field need to develop the necessary skills to be able to compete for regulatory affairs jobs.
A list of some of the core skills for regulatory affairs jobs for MBBS and BDS graduates is provided below:
Regulatory Affairs Knowledge
A good understanding of regulatory affairs is critical for anyone who wants to pursue a career in the field. As a result, it is important to develop a comprehensive understanding of the subject.
The regulatory affairs knowledge should include an understanding of regulatory submissions, product registration, clinical trials, good clinical and manufacturing practices (GCP, GMP), drugs and medical device regulations, pharmacovigilance, and related subjects.
Develop Industry-Relevant Skills
An MBBS or BDS degree provides extensive healthcare knowledge, but employers may also expect candidates to understand how the healthcare industry operates outside clinical settings.
This is where structured non-clinical healthcare training can be valuable. Academically’s non-clinical course can help healthcare graduates understand different career opportunities beyond traditional clinical practice while developing skills relevant to healthcare industry roles.
For candidates specifically targeting regulatory affairs jobs for MBBS graduates, such training can help bridge the gap between medical education and industry expectations. Your knowledge of medical terminology, diseases, treatment protocols, pharmacology, clinical documentation, and patient safety can be combined with regulatory and industry-oriented knowledge to create a stronger professional profile.
Scientific Writing
Scientific writing is one of the most sought after skills for regulatory affairs roles. Regulatory affairs involves a significant amount of documentation, and one of the most common roles in the field is a regulatory medical writer.
As a result, it is critical to develop skills in scientific writing to be able to pursue a wide range of regulatory affairs jobs for MBBS and BDS graduates.
Attention To Detail
Regulatory affairs requires extremely high levels of attention to detail. A minor error in the documentation can result in the rejection of a product or a legal issue.
Regulatory professionals need to be able to analyze data, documents, submission dossiers, and related materials. The documents normally contain a significant amount of statistical data, references, product details, version numbers, dates, and other information.
Research Skills
Regulatory affairs involves a significant amount of research, including but not limited to research on products, regulations, guidelines, and related subjects. As a result, research skills are a critical skill for regulatory affairs jobs.
Communication And Teamwork
Regulatory affairs is not a solo role but rather a collaborative effort. There is a significant amount of interaction and collaboration between regulatory affairs, quality, pharmacovigilance, clinical research, medical affairs, and other departments.
Effective communication and collaboration are critical, irrespective of the area of regulation one works in.
What Does A Day In The Life Of A Regulatory Affairs Professional Look Like?
A common misconception about a career in regulatory affairs is that it primarily involves paperwork and can be boring.
The truth is far removed from this belief, but it is necessary to take a step back and analyze the work involved.
A regulatory affairs professional can have a wide range of responsibilities, depending on the organization they work in, the products they handle, and the services they provide.
For example, a regulatory professional who works in the medical device space will have significantly different responsibilities compared to someone who works in the pharmaceutical space.
That said, the core of regulatory affairs revolves around product, documentation, and compliance.
As a result, a regulatory professional’s day normally revolves around the following activities:
- Review regulatory updates
- Hold a meeting with the clinical or medical team
- Review submission document and update it based on feedback
- Update submission records
- Prepare documentation and records for submission
One day, a regulatory professional may spend the majority of their time reviewing regulations, analyzing the guidelines, and preparing a summary for the medical team. A different day may involve preparing and reviewing submission documents and spending a significant amount of time in meetings with the medical and clinical teams.
Another day could involve reviewing requirements and analyzing the necessary documentation to launch a healthcare product in a specific territory. In short, a regulatory professional’s activities will depend on a number of factors.
It is critical to keep in mind that regulatory affairs is not a clinical role but one that is primarily focused on products, documentation, and compliance.
Regulatory Affairs Vs Clinical Practice: Which One Is Better?
MBBS and BDS graduates often face a dilemma when it comes to choosing between a career in clinical practice and a career in the healthcare industry. For the purposes of this discussion, healthcare industry will primarily refer to regulatory affairs, medical device regulatory affairs, pharmacovigilance, and other similar fields.
The two options are not mutually exclusive, and one can pursue a career in clinical practice and transition into regulatory affairs later or vice versa.
However, it is important to be aware of the differences between the two career paths.
A comparison of the two career paths is provided below:
Regulatory affairs and clinical practice are fundamentally different, and the choice between the two will depend on a number of factors, including but not limited to the following:
- Nature of work
- Location
- Patient interaction
- Documentation
- Career growth
- Work-life balance
- Income potential
It is normal for medical and dental graduates to struggle with this decision since both the career paths have their own advantages and disadvantages.
How Can MBBS/ BDS Graduate Transition Into Regulatory Affairs?
Anyone who wants to transition into regulatory affairs as an MBBS or BDS graduate needs to understand their strengths and weaknesses, the requirements of the target job role, and the steps that they need to take to gain the necessary skills.
The steps outlined below can be used as a guideline by medical and dental graduates to prepare themselves for a career in regulatory affairs.
1. Understand The Basics Of Regulatory Affairs
An aspiring regulatory professional needs to understand the subject first. This will involve identifying the different roles, responsibilities, and areas of regulation.
2. Learn The Guidelines
One of the easiest ways to get started is by learning the guidelines and requirements. International guidelines are normally a good place to start.
3. Develop Scientific Writing Skills
Regulatory affairs is a documentation-intensive role, and scientific writing is one of the most sought-after skills in the industry. Aspiring regulatory professionals can significantly benefit from developing scientific writing skills.
4. Gain Practical Knowledge And Experience
Employers may prefer candidates who can demonstrate an understanding of how regulatory work is performed in real-world settings.Courses, internships, and projects can be a great way to gain practical exposure to the field.
5. Update Your Resume
MBBS and BDS graduates do not always have a deep understanding of the skills and experiences that are relevant to a regulatory affairs role. As a result, it is important to update one’s resume based on the requirements of a specific job description.
6. Search For Relevant Entry-Level Job Roles
Entry-level job roles can be challenging for fresh graduates, but there are a number of options for someone with an MBBS or BDS qualification. Some of the most common entry-level job roles that MBBS and BDS graduates can consider include the following:
- Regulatory affairs associate
- Regulatory affairs executive
- Regulatory associate
- Medical writer
- Regulatory medical writer
- Clinical research associate
- Regulatory operations associate
- Medical device regulatory associate
Finding suitable entry-level opportunities can be challenging because job portals may show a large number of positions that are either unrelated to your background or require prior industry experience. Jobslly can make this process more focused by helping healthcare professionals discover relevant opportunities across non-clinical healthcare roles.
MBBS and BDS graduates can use the platform to explore openings in areas such as regulatory affairs, medical writing, pharmacovigilance, clinical research, medical affairs, and other healthcare industry functions. This can be particularly useful when you are transitioning from clinical practice and are unsure which job titles to search for.
Final Takeaway
An MBBS or BDS degree does not have to lead exclusively to clinical practice.The healthcare industry needs professionals who understand medicine and can apply that knowledge to research, regulation, safety, compliance, medical writing, and product development.
That is why regulatory affairs jobs for MBBS graduates can represent a promising non-clinical career pathway. BDS graduates can also explore this field, particularly across medical device, dental product, clinical research, and regulatory functions.
Your degree gives you the healthcare foundation. Regulatory training, scientific writing, practical exposure, and industry awareness can help you turn that foundation into a regulatory affairs career.If you like science, documentation, research, compliance, and working behind the scenes to help healthcare products reach patients safely, regulatory affairs could be worth exploring.
