PG Diploma in Pharma Regulatory Affairs is a 1- year postgraduate course. Drug Regulatory Affairs is a course that provides a comprehensive education that is focused on drug safety and quality compliance. This course will enable you to understand regulatory affairs within the pharmaceutical industry, and it will help you gain the relevant skills necessary to pursue careers in the field. Demand for pharmaceutical regulatory affairs professionals is high, and career opportunities are numerous.
This course is suited for anyone who wants to learn about regulatory affairs. While no prior professional experience is necessary, it is helpful to have a strong scientific background in the relevant pharmaceutical industry disciplines, such as pharmacology, pharmaceutics, or medicine. You can also choose to explore other related fields such as molecular biology and toxicology, or a similar one such as food science.
PG Diploma in Pharma Regulatory Affairs course, students are trained in enterprise management leadership, advanced business concepts, technology management, and advanced pharmaceutical management. Students will also learn the basics of catering to the contemporary management needs of the pharmaceutical industry.
PG Diploma in Pharma Regulatory Affairs Highlights
Course Level |
PG Diploma in Pharma Regulatory Affairs |
Duration of the Course |
1 year |
Examination Type |
Semester and Annual |
Eligibility |
10+2 from a recognized educational Board (at least 50% marks) with B.Phrma course |
Admission Process |
Merit-based |
Average Course Fee |
INR 36,000 to 1.5 Lakhs |
Average Salary |
INR 1 Lakhs - INR 2.5 Lakhs |
Top Recruiting Companies |
AP Labs, Cipla, Ranbaxy, Biocon, Glenmark Pharmaceuticals, Aurobindo Pharma, Central Forensic Lab, Documentation Examination Laboratories at Central and State Level, etc |
Top Job Areas |
The medical industry, research labs, agriculture, pharmaceutical companies, or any academic institutions as well |
Top Job Positions |
Clinical Researcher, Biochemist, Medical Coder, Asst. Professor, Medical Review Officer, Research Analyst, Quality Assurance, Operations Manager, Product Development Manager, Medical Writer, Sr Executive Assistant, etc. |
Eligibility Criteria for PG Diploma in Pharma Regulatory Affairs
1. Graduation (B.Pharm.), completed from a recognized university.
2. A minimum aggregate score of 50% (45% for SC/ST/OBC candidates) at the level of graduation.
3. Graduation needs to have been completed in any of: B.Pharm in Pharmacy/ Pharmacology, B.Sc. in Biology/ Physics/ Zoology/ Genetics/ Chemistry/ Biochemistry
4. Bachelor’s degree in Home Science/ Microbiology/ Biotechnology/ Botany, B.Sc. Agriculture/ B.Phs./ BDS/ MBBS/ B.Pharm
5. Candidates awaiting their graduation-level examination results are also eligible to apply on a provisional basis.
Admission Process
1. Colleges publish admission notices on their website from June when most Indian universities would have finished degree exams.
2. Candidate to apply for each college, as each college considers each mark the cut-off mark.
3. Some private colleges and deemed universities perform their counselling process by conducting their university-level entrance exams.
4. Some colleges require a minimum of 50% aggregate in the qualifying examination.
5. Candidates who qualify for the test are called for an interview before the final seat allotment.
6. Documents like mark sheets, photographs, signatures and transfer certificates must be scanned and uploaded online to the portal.
7. All documents must be in a specific format and size only to be accepted.
Career after PG Diploma in Pharma Regulatory Affairs
This career requires a combination of legal knowledge and strong interpersonal skills. Careers in the Drug Regulatory Affairs sector are growing rapidly. This is one of the most well-paid fields in the medical industry. The course is primarily designed to prepare qualified candidates for administrative positions in the pharmaceutical industry. In addition, it provides an opportunity to prepare for work on designing, operating management systems, advising and understanding management personnel issues.
Successful postgraduates of the course are hired in capacities such as Researcher, Chemist, technical personnel, and Pharmaceutical Manager, in both government and private sectors, research institutes, universities, the pharmaceutical industry, hospitals, the healthcare industry, drug manufacturing companies, etc.
Job Position |
Job Description |
Clinical Researcher |
They are supposed to work in the labs and carry out experiments and research. These kinds of jobs play an important role in contributing to the biochemical sector |
Research Scientist |
A research scientist is appointed to perform in the field and design and conduct experiments that can help in researching biochemicals. |
Lab Technician |
Lab Technicians are appointed by the pathology labs and they are involved in testing and preparing diagnoses reports for patients. |
Medical Coder |
A Medical Coder translates the descriptions of medical diagnoses and procedures into universal medical code numbers. |
Scientific Editor |
A Scientific editor is appointed with Scientific journals and magazines for editing and compiling articles and research papers submitted for publication. |
You can also make your career in the Pharmaceutical Management & marketing field as a Production Manager, Medical Representative, Area Manager, etc.
Blood Service
Agriculture and Fisheries
Cosmetic Industries
Drug Manufacturing Companies
Public Health Laboratories
Forensic Science
Research Departments
Hospitals
Educational Institutes
PG Diploma in Pharma Regulatory Affairs Syllabus
Semester I |
Semester II |
Principles and Practice of Management |
Marketing Management |
Basics of Marketing |
Human Resource Management |
Managerial Economics |
Market Research |
Management Information System |
Macro Economics |
Finance and Management Accounting |
Paradigms of the Pharmaceutical Industry |
Anatomy, Physiology and Pharmacology |
Pharma Sales and Distribution Management |
Pharma Business Environment |
Pharma Products and Brand Management |