Amity University Noida MBA Admissions 2025
Amongst top 3% universities globally (QS Rankings)
PGD Regulatory Affairs aims to provide students with advanced education and training in regulatory sciences and equip them to understand and address the challenges of a constantly changing global environment. It is a one-year full-time postgraduate diploma course that offers various job opportunities to graduates with an average package of Rs. 5.5 LPA.
The programme's main goal is to guarantee the efficacy and safety of a broad range of goods, including pharmaceuticals, biopharmaceuticals, medical equipment, veterinary care, cosmetics, agrochemicals, and complementary and alternative therapies. PGD Regulatory Affairs covers topics such as regulatory compliance, drug development, quality assurance, and regulatory submissions.
Particulars | Values |
---|---|
Degree Name | PGD Regulatory Affairs |
Degree Type | PG Diploma |
Degree Duration | 1-year |
Eligibility Criteria | |
Admission process | Merit-based |
Average Fees | Rs. 50,000- Rs. 2 Lakhs. |
Average Salary | Rs. 5.5 LPA |
Job profiles | Production Chemist, Pharmacoeconomic Specialist, Regulatory Affairs Officer, Clinical Research Scientist |
Top recruiters | Cognizant, Covance, Lupin, Amplo, Genpact, VyasLife |
To be eligible for a PGD Regulatory Affairs, the candidates should satisfy all the criteria of the particular college. The eligibility criteria vary by institute, however, some basic conditions are stated as follows:
The candidate must have graduated with a B.Pharm, B.Sc Botany, B.Sc Biochemistry, B.Sc Zoology, B.Sc Chemistry, Bsc Life Sciences, B.Sc Biotechnology, B.Sc Microbiology or equivalent from a recognised institution.
The candidate must have scored a minimum of 50 per cent in their respective degrees.
The candidate must be a working professional.
The candidate's merit is the only consideration in the admissions process. To get admitted to the institution of their choice, applicants must follow the general process of admission stated below:
Candidates must either visit the college campus or fill out the application form through the college’s website.
They must ensure that all the relevant documents are attached to the application form.
The admission criteria vary by the institute, hence, candidates need to satisfy the cutoff of the particular college to get admission there.
There are no known entrance exams for PGD Regulatory Affairs in India. Admission to this course is purely based on the merit scores in the majority of colleges. However, candidates must check the admission criteria of any particular institute beforehand.
Admission into PGD Regulatory Affairs is granted to students who satisfy the merit cutoff percentage, ranks, or scores of colleges. These cutoff scores may vary by the institute based on their criteria for admission. A candidate must clear the cutoff of their desired college to get admission there.
To excel in a PG Diploma in Regulatory Affairs, several key skills are essential. Developing these skills can help individuals succeed in the dynamic and challenging field of regulatory affairs:
Analytical Skills
Attention to Detail
Communication Skills
Organisational Skills
Problem-Solving Skills
Legal and Regulatory Knowledge
Ethical Awareness
The academic curriculum for a PGD Regulatory Affairs differs by the institute. It is a one-year full-time programme with the following topics under study according to the University of Mumbai:
1st Semester | 2nd Semester |
---|---|
Basic ICH Requirement | Regulatory Filing systems in US |
Regulatory Filing systems for Active Pharmaceutical Ingredients in different countries | Registration procedures in various countries |
Regulatory Filing systems in Europe | Pharmacovigilance in EU/US |
- | Audit Checklist |
The average cost of a postgraduate diploma in regulatory affairs varies based on the institute, the location, and other factors. Some prestigious institutes may have higher fees, while others may be more affordable. The average fee for the course would be Rs. 50,000- Rs. 2 Lakhs.
PGD Regulatory Affairs provides a bright future for those looking to progress in fields like biotechnology, healthcare, medical devices, and pharmaceuticals. Regulatory affairs specialists are essential in guaranteeing adherence to rules, expediting product authorisation, and negotiating the intricate regulatory terrain. The need for qualified experts in this industry is rising as regulatory compliance and quality assurance become more and more important.
Graduates can look for jobs in India and beyond in regulatory affairs, quality assurance, compliance, and related fields. There are also opportunities for research in regulatory affairs, contributing to the development of new regulations and standards.
After completing a PG Diploma in Regulatory Affairs, graduates can explore various career options in industries such as pharmaceuticals, biotechnology, medical devices, and healthcare. A constant demand exists for skilled professionals to enter the business. Some of the career options are listed below:
Production Chemist | Production chemists supervise the production of chemical products, making sure that quality, safety, and efficiency requirements are satisfied. |
Pharmacoeconomic Specialist | Pharmacoeconomic experts assist healthcare organisations in making well-informed decisions regarding healthcare spending by analysing the cost-effectiveness of pharmaceutical goods and therapies. |
Regulatory Affairs Officer | Regulatory Affairs Officers ensure that laws controlling the creation, production, and distribution of medications, medical equipment, and healthcare supplies are followed. |
Clinical Research Scientist | Clinical research scientists plan, carry out, and assess clinical studies to determine the security and effectiveness of novel medical procedures. They are essential to expanding our understanding of medicine and enhancing patient care. |
Some of the top recruiters for PG Diploma in Regulatory Affairs graduates include pharmaceutical companies, biotechnology firms, medical device companies, contract research organisations (CROs), regulatory consulting firms, and government regulatory agencies. Some of the top recruiters are:
Cognizant
Covance
Lupin
Amplo
Genpact
VyasLife
Graduates of PGD Regulatory Affairs specialise in the regulatory needs of specific industries, such as pharmaceuticals and medical devices. By offering chances for growth and adaptability in positions in regulatory affairs, quality assurance, and compliance, this certification improves job prospects. Additionally, since regulatory affairs experts are in greater demand globally, it opens doors to opportunities across the globe.
The expected salary after completing a PG Diploma in Regulatory Affairs can vary depending on factors such as the employer, location, job role, and level of experience. Below are some of the high-paying job profiles and their corresponding yearly average salaries:
Role | Average Salary |
---|---|
Production Chemist | Rs. 4.2 LPA |
Pharmacoeconomic Specialist | - |
Regulatory Affairs Officer | Rs. 3.4 LPA |
Clinical Research Scientist | Rs. 7.7 LPA |
Source: Ambition Box
Some of the best colleges in the country offer PGD Regulatory Affairs, each having a specialised curriculum for the same. A student has a list of options to choose from. A few of the top institutions are as follows:
Colleges | Fee Structure (Entire Course) |
---|---|
Rs. 1.10 Lakhs | |
Jamia Hamdard School of Open and Distance Learning, New Delhi | - |
- | |
- | |
- | |
- | |
- | |
Rs. 26,300 | |
Mumbai University | - |
Government colleges usually charge a much lower tuition fee as compared to private institutions. Hence, students can expect a good return on their investment. A top government college offering PGD Regulatory Affairs is:
Colleges | Fee Structure (Entire Course) |
---|---|
Institute of Good Manufacturing Practices India, New Delhi | Rs. 1.10 Lakhs |
Mumbai University | - |
Private institutions usually charge a higher tuition fee as compared to government colleges. However, students can expect a highly qualified faculty along with a multi-purpose college campus. The following private colleges offer PGD Regulatory Affairs:
Colleges | Fee Structure (Entire Course) |
---|---|
Jamia Hamdard School of Open and Distance Learning, New Delhi | - |
JSS College of Pharmacy, Mysore | - |
JSS College of Pharmacy, Ooty | - |
JS University, Shikohabad | - |
National College, Tiruchirappalli | - |
Priyadarshini College of Pharmacy, Tumkur | - |
Ramniranjan Jhunjhunwala College, Mumbai | Rs. 26,300 |
The PGD Regulatory Affairs provides a promising and fulfilling professional path, which improves employment chances in regulatory affairs, quality assurance, and related sectors. Graduates are prepared to handle the regulatory environment's complexity, assure regulatory compliance, and expedite product approvals.
Graduates can look for jobs in India and beyond in regulatory affairs, quality assurance, compliance, and related fields. There are also opportunities for research in regulatory affairs, contributing to the development of new regulations and standards.
There are various kinds of job profiles within this sector like Production Chemist, Pharmacoeconomic Specialist, Regulatory Affairs Officer, and Clinical Research Scientist.
The average PGD Regulatory Affairs salary that a graduate can earn is Rs. 5.5 LPA.
The candidate must have graduated with a B.Pharm, B.Sc (Botany, Zoology, Chemistry, Biochemistry, Biotechnology, Microbiology, Life Sciences) or equivalent from a recognized institution with a minimum of 50 per cent.
Cognizant, Covance, Lupin, Amplo, Genpact, and VyasLife are some of the top recruiters.
The duration of a PGD Regulatory Affairs is one year.
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Ranked amongst top 3% universities globally (QS Rankings)
Ranked amongst top 3% universities globally (QS Rankings).
Ranked amongst top 3% universities globally (QS Rankings)
Ranked amongst top 3% universities globally (QS Rankings)