PG Diploma in Regulatory Affairs: Duration, Eligibility, Syllabus, Colleges, Fees, Scope

PG Diploma in Regulatory Affairs: Duration, Eligibility, Syllabus, Colleges, Fees, Scope

Edited By Team Careers360 | Updated on Mar 22, 2024 12:13 PM IST

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.

This Story also Contains
  1. Highlights about PGD Regulatory Affairs
  2. PGD Regulatory Affairs Eligibility
  3. PGD Regulatory Affairs Admission
  4. PGD Regulatory Affairs Entrance Examinations
  5. Cutoff of Top Colleges
  6. Required Skills for PGD Regulatory Affairs
  7. PGD Regulatory Affairs Syllabus
  8. PGD Regulatory Affairs Fees Structure
  9. Scope of PGD Regulatory Affairs
  10. Career Options after PGD Regulatory Affairs
  11. Benefits of PGD Regulatory Affairs
  12. Expected Salary after PGD Regulatory Affairs
  13. List of Top Colleges in India Offering PGD Regulatory Affairs
  14. Top Government Colleges in India Offering PGD Regulatory Affairs
  15. Top Private Colleges in India Offering PGD Regulatory Affairs

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.

Highlights about PGD Regulatory Affairs

Particulars

Values

Degree Name

PGD Regulatory Affairs

Degree Type

PG Diploma

Degree Duration

1-year

Eligibility Criteria

B.Pharm, B.Sc, PhD and Pharmaceutical Professionals.

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

PGD Regulatory Affairs Eligibility

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:

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Amongst top 3% universities globally (QS Rankings)

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Ranked as India’s #1 Not for profit pvt. University by India Today

PGD Regulatory Affairs Admission

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.

PGD Regulatory Affairs Entrance Examinations

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.

Cutoff of Top Colleges

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.

Required Skills for PGD Regulatory Affairs

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

PGD Regulatory Affairs Syllabus

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

PGD Regulatory Affairs Fees Structure

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.

Scope of PGD Regulatory Affairs

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.

Career Options after PGD Regulatory Affairs

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.

Top Recruiters

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

Benefits of PGD Regulatory Affairs

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.

Expected Salary after PGD Regulatory Affairs

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

List of Top Colleges in India Offering PGD Regulatory Affairs

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:

Top Government Colleges in India Offering PGD Regulatory Affairs

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

-

Top Private Colleges in India Offering PGD Regulatory Affairs

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.

Frequently Asked Questions (FAQs)

1. What is the scope of PGD Regulatory Affairs?

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.

2. What are Career Options after a PGD in Regulatory Affairs?

There are various kinds of job profiles within this sector like Production Chemist, Pharmacoeconomic Specialist, Regulatory Affairs Officer, and Clinical Research Scientist.

3. What is the average salary one can expect after completing a PGD Regulatory Affairs?

The average PGD Regulatory Affairs salary that a graduate can earn is Rs. 5.5 LPA.

4. What is the eligibility criteria to pursue a PGD Regulatory Affairs?

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.

5. Who are the top recruiters after completing a PGD Regulatory Affairs?

Cognizant, Covance, Lupin, Amplo, Genpact, and VyasLife are some of the top recruiters.

6. What is the duration of a PGD Regulatory Affairs?

The duration of a PGD Regulatory Affairs is one year.

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