Overview
The Master of Pharmacy (M.Pharm.) in Regulatory Affairs is a two-year postgraduate programme designed to develop professionals with comprehensive knowledge of national and international pharmaceutical regulations governing the development, manufacture, registration, marketing, and post-marketing surveillance of healthcare products. The programme provides specialized education in regulatory requirements applicable to pharmaceuticals, biologicals, biosimilars, vaccines, medical devices, cosmetics, herbal products, food products, nutraceuticals and combination products. Students gain expertise in preparing regulatory documentation, understanding global regulatory frameworks, ensuring compliance with Good Regulatory Practices (GRP), and obtaining marketing authorization across regulated and emerging markets. The curriculum integrates theoretical knowledge with practical exposure through industrial projects, case studies, regulatory writing assignments, and interaction with regulatory professionals, making graduates industry-ready for diverse regulatory roles.
Programme Highlights (USPs) :
- Industry-oriented curriculum aligned with current global regulatory requirements.
- Comprehensive coverage of regulated and semi-regulated markets.
- Training in preparation of regulatory dossiers (CTD/eCTD).
- Hands-on exposure to electronic submissions and regulatory software.
- Practical case studies from pharmaceutical, biotechnology and medical device industries.
- Interaction with experienced regulatory professionals and industry experts.
- Industrial visits, internships and research-oriented dissertation.
- Exposure to regulatory intelligence and compliance management.
- Training in regulatory writing and scientific documentation.
- Focus on quality systems, GMP, GLP, GCP, GDP and pharmacovigilance.
- Opportunities for participation in seminars, workshops, conferences and certification programmes.
Excellent placement support through industry collaborations
Global Regulatory Exposure :
Students gain knowledge of regulations applicable to major regulatory agencies including:
- US FDA (United States)
- EMA (European Medicines Agency)
- MHRA (United Kingdom)
- TGA (Australia)
- Health Canada
- PMDA (Japan)
- CDSCO (India)
- WHO Guidelines
- ICH Guidelines
- PIC/S
- ASEAN Regulatory Framework
- GCC Countries
- Brazil (ANVISA)
- CIS Countries
- Emerging Markets
Key Areas of Study :
The programme covers:
- Drug Regulatory Affairs
- Pharmaceutical Product Registration
- Regulatory Documentation
- CTD and eCTD Submission
- Drug Master File (DMF)
- Investigational New Drug (IND)
- New Drug Application (NDA)
- Abbreviated New Drug Application (ANDA)
- Marketing Authorization Applications (MAA)
- Clinical Trial Regulations
- Pharmacovigilance
- Medical Device Regulations
- Cosmetics Regulations
- Biologicals and Biosimilars Regulations
- Vaccine Regulations
- Nutraceutical and Food Regulations
- Herbal Product Regulations
- Intellectual Property Rights
- Regulatory Writing
- Quality Assurance and Compliance
- Validation and Qualification
- GMP, GLP, GCP and GDP
- Risk Management
- Regulatory Audits
- Regulatory Intelligence
- Data Integrity
Electronic Regulatory Submissions
The programme extends over two academic years (Four Semesters).
- First Year: Course work consisting of theory, practicals, seminars and assignments.
- Second Year: Research project, dissertation work, seminars and viva-voce examination.
Eligibility Criteria
For Indian Candidates
Candidates must:
- Possess a Bachelor’s Degree in Pharmacy (B.Pharm.) from an AICTE/PCI/UGC recognized institution.
- Obtain a minimum of 55% aggregate marks (50% for reserved categories as per Government norms).
- Possess a valid GPAT score where applicable as per admission regulations.
Sponsored Candidates
Candidates sponsored by industry should possess:
- Minimum two years of full-time professional experience in pharmaceutical industry, research organizations, government departments or educational institutions.
Foreign/NRI/OCI/PIO Candidates
Admissions shall be governed by the rules and regulations prescribed by the competent statutory authorities from time to time.
Intake
Approved Intake: 15 Students
Attendance Requirement
Students must maintain minimum 80% attendance separately in each theory, practical and other academic activities as prescribed by the University and PCI regulations.
 | Name: Dr. Shaikh N. S. Designation: Professor Department in-charge Qualification: M Pharm, PhD. |  | Name: Dr. Nagoba. S. N. Designation: Professor Qualification: M Pharm, PhD. |
 | Name: Ms. Khadkutkar V. K. Designation: Assistant Professor Qualification: M Pharm, PhD. |  | Name: Mr. Hucche B. S. Designation: Assistant Professor Qualification: M Pharm. |
 | Name: Mr. Kazi W. B. Designation: Assistant Professor Qualification: M Pharm. |  | Name: Ms. Shaikh Atiya Layakh Ali Designation: Assistant Professor Qualification: M Pharm. |
 | Name: Ms. Bharti Ashvini Eshwar Designation: Assistant Professor Qualification: M Pharm. |
The programme adopts a student-centred learning approach through:
- Interactive classroom teaching
- Case-based learning
- Problem-based learning
- Industrial case studies
- Laboratory demonstrations
- Regulatory dossier preparation
- Regulatory writing exercises
- Workshops and guest lectures
- Industrial visits
- Journal clubs
- Seminars and presentations
- Assignments and quizzes
- Research projects
- Dissertation work
- Self-directed learning
- E-learning resources
Students undertake research projects addressing contemporary regulatory challenges in collaboration with faculty and industry experts. The dissertation develops competencies in:
- Research methodology
- Literature review
- Data analysis
- Regulatory documentation
- Scientific writing
Presentation skills
Students will acquire:
- Comprehensive understanding of global regulatory systems.
- Practical experience in regulatory submissions.
- Expertise in dossier compilation and lifecycle management.
- Knowledge of international regulatory guidelines.
- Skills in regulatory writing and scientific communication.
- Exposure to compliance audits and inspections.
- Understanding of pharmacovigilance and risk management.
- Experience with current industry practices.
Graduates can pursue careers in:
- Pharmaceutical Companies
- Biotechnology Companies
- Medical Device Industry
- Vaccine Manufacturers
- Cosmetic Industry
- Nutraceutical Industry
- CROs (Contract Research Organizations)
- CDMOs
- Regulatory Consulting Firms
- Government Regulatory Authorities
- Clinical Research Organizations
- Healthcare Companies
- Quality Assurance Departments
- Academic and Research Institutions
Job Profiles :
- Regulatory Affairs Executive
- Regulatory Affairs Associate
- Regulatory Affairs Specialist
- Regulatory Affairs Manager
- Regulatory Compliance Officer
- Regulatory Intelligence Analyst
- Dossier Preparation Specialist
- Medical Writer
- Regulatory Submission Specialist
- Drug Safety Associate
- Pharmacovigilance Associate
- Clinical Research Associate
- Documentation Executive
- Quality Assurance Executive
- Validation Executive
- Product Registration Officer
- Excellent career prospects in India and abroad.
- High demand for trained regulatory professionals.
- Opportunities across pharmaceuticals, biologics, medical devices and healthcare sectors.
- Exposure to global regulatory standards and documentation.
- Strong industry-academia interaction.
- Research-driven and practice-oriented curriculum.
- Development of technical, analytical and leadership skills.
- Preparation for careers in regulatory strategy, compliance and product registration.
Graduates may pursue:
- Ph.D. in Pharmaceutical Sciences
- Ph.D. in Regulatory Science
- Postdoctoral Research
- International Regulatory Certification Programmes
- Specialized Training in Pharmacovigilance, Medical Writing and Clinical Research
The programme encourages collaboration with:
- Pharmaceutical industries
- Biotechnology companies
- Medical device manufacturers
- Clinical research organizations
- Regulatory consulting firms
- Government regulatory agencies
- Research laboratories
Students are encouraged to participate in internships, industrial projects, collaborative research and professional certification programmes.
With increasing global harmonization of pharmaceutical regulations and expanding healthcare markets, Regulatory Affairs professionals are among the most sought-after experts in the pharmaceutical and life sciences industries. Graduates of this programme are well-equipped to contribute to product development, regulatory compliance, global product registrations, lifecycle management and strategic regulatory decision-making, ensuring safe, effective and quality healthcare products reach patients worldwide.