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M-PHARM in Regulatory Affairs at SRM Institute of Science and Technology
Chengalpattu, Tamil Nadu
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About the Specialization
What is Regulatory Affairs at SRM Institute of Science and Technology Chengalpattu?
This Regulatory Affairs program at SRM Institute of Science and Technology focuses on the intricate global and Indian pharmaceutical regulatory landscape. It equips students with essential knowledge of drug approval processes, stringent quality standards, and intellectual property management. This specialization is crucial for ensuring safe and effective healthcare products reach the market, addressing a high demand in India''''s booming pharmaceutical and biotechnology sectors.
Who Should Apply?
This program is ideal for B.Pharm graduates aiming for a career in drug regulation, quality assurance, or clinical research within the pharmaceutical industry. It also suits working professionals in pharma R&D or manufacturing seeking to upskill and specialize in regulatory compliance. Individuals keen on understanding the complex legal frameworks governing drug development and marketing, both in India and internationally, will find this program highly beneficial.
Why Choose This Course?
Graduates of this program can secure rewarding roles as Regulatory Affairs Associates, Quality Assurance Managers, Pharmacovigilance specialists, or Clinical Research Coordinators in leading Indian pharma companies and multinational corporations operating in India. Entry-level salaries typically range from INR 3-6 LPA, with significant growth potential as experience accrues. The program comprehensively prepares students for leadership positions in regulatory strategy and compliance, aligning with global professional certification standards.
Student Success Practices
Foundation Stage
Master Core Regulatory Principles- (Semester 1)
Focus on an in-depth understanding of the Drug and Cosmetic Act, ICH guidelines, and Good Clinical Practice. Utilize online regulatory databases like CDSCO and FDA websites, and actively participate in case studies to grasp practical implications and applications of these fundamental principles.
Tools & Resources
CDSCO website, FDA website, ICH Guidelines documents, Case studies
Career Connection
This builds a strong foundational base for all future regulatory roles, establishing you as a knowledgeable resource for compliance queries, critical for entry-level positions.
Develop Scientific Writing & Communication Skills- (Semester 1)
Actively participate in journal clubs, consistently write concise summaries of complex research papers, and regularly practice formal presentations. Leverage writing tools like Grammarly and engage in peer review sessions to refine your scientific communication abilities.
Tools & Resources
Grammarly, Journal Club activities, Presentation software
Career Connection
Strong written and oral communication is vital for dossier preparation, report writing, and effective interaction with regulatory agencies, significantly enhancing career progression in document-heavy roles.
Excel in Lab & Practical Skills- (Semester 1)
Pay close attention during Regulatory Affairs Lab sessions to gain hands-on experience with documentation, quality control procedures, and various analytical techniques. Actively seek additional practice and engage with simulation software if available to reinforce practical proficiency.
Tools & Resources
Lab manuals, Quality control equipment, Documentation templates
Career Connection
Practical proficiency is highly valued in quality assurance and regulatory submissions roles, directly impacting your employability and effectiveness in a professional setting.
Intermediate Stage
Engage in Industry-Specific Case Studies- (Semester 2)
Actively participate in discussions and projects involving real-world scenarios in Intellectual Property Rights, Pharmacovigilance, and Drug Discovery. Analyze recent regulatory approvals or rejections to understand the practical application of theoretical concepts in the Indian context.
Tools & Resources
Industry news and journals, Regulatory databases, Company reports
Career Connection
This practice helps develop critical thinking and problem-solving skills, crucial for navigating the complex regulatory challenges prevalent in the Indian pharmaceutical industry, enhancing your analytical capabilities.
Build a Professional Network- (Semester 2)
Attend industry webinars, guest lectures, and workshops organized by the department or external bodies like the Indian Pharmaceutical Association (IPA) or Drug Information Association (DIA). Proactively connect with faculty, alumni, and industry professionals on platforms like LinkedIn.
Tools & Resources
LinkedIn, Professional association events (IPA, DIA), Departmental seminars
Career Connection
Networking opens doors to mentorship opportunities, potential internship leads, and invaluable insights into emerging industry trends, significantly accelerating your career growth and opening new avenues.
Advance Software Proficiency- (Semester 2)
Gain hands-on experience with specialized software commonly used in regulatory affairs, such as eCTD submission tools or pharmacovigilance databases. Actively seek out tutorials or short online courses to master the practical application of these essential tools.
Tools & Resources
eCTD software demos, Pharmacovigilance databases (e.g., VigiFlow tutorials), Online courses
Career Connection
Proficiency in these specialized technologies is a significant asset for roles involving dossier management, safety data analysis, and regulatory operations, making you a more competitive candidate.
Advanced Stage
Focus on Research Project Excellence- (Semesters 3-4)
Dedicate substantial effort to your Research Work (Phase I & II), ensuring a robust literature review, sound methodology, meticulous execution, and clear data interpretation. Seek regular, constructive feedback from your research guide and actively aim for publication in reputable journals or patent filing.
Tools & Resources
Research labs, Statistical software (e.g., SPSS, R), Academic journals
Career Connection
A high-quality research project significantly enhances your resume, showcases independent thinking and problem-solving, and can directly lead to advanced R&D or specialized regulatory strategy roles.
Targeted Internship & Placement Preparation- (Semesters 3-4)
Secure a long-term internship in a regulatory department of a pharmaceutical company, CRO, or consulting firm during your final semesters. Simultaneously, prepare rigorously for placements by honing interview skills through mock interviews and tailoring your resume to specific job requirements.
Tools & Resources
Career services, Mock interview platforms, Company career pages, Resume builders
Career Connection
Practical industry experience combined with strong interview performance is crucial for securing desired positions in the competitive regulatory affairs job market, facilitating a smooth transition into your career.
Continuous Learning & Certifications- (Semesters 3-4 and beyond)
Stay updated with the latest regulatory changes and guidelines by regularly reading industry publications and attending advanced workshops. Consider pursuing professional certifications like those offered by the Regulatory Affairs Professionals Society (RAPS) or specific pharmacovigilance certifications.
Tools & Resources
RAPS certifications, Industry journals (e.g., Pharma Pathways), Continuous professional development courses
Career Connection
This demonstrates a strong commitment to lifelong learning and boosts your credibility and expertise in the dynamic and evolving regulatory field, opening doors to leadership and specialized expert roles.
Program Structure and Curriculum
Eligibility:
- A candidate who has passed B. Pharm Degree examination of SRM Institute of Science and Technology or any other recognized Indian or foreign University established or incorporated by or under law with a minimum of 50% aggregate marks in B.Pharm degree examination.
Duration: 2 years (4 semesters)
Credits: 82 Credits
Assessment: Internal: 40%, External: 60%
Semester-wise Curriculum Table
Semester 1
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| MPR21101T | Pharmaceutical Regulatory Science - I | Core | 4 | Regulatory affairs introduction, Drug and Cosmetic Act 1940, Regulatory agencies (CDSCO, FDA), Investigational New Drug (IND) applications, ICH Guidelines |
| MPR21102T | Good Clinical Practice | Core | 4 | Clinical trial phases, Ethical considerations in clinical research, Informed consent process, Institutional Review Board (IRB)/Ethics Committee (EC), Investigator responsibilities |
| MPR21103T | Pharmaceutical Quality Assurance | Core | 4 | Quality management systems, Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Quality control principles, Documentation practices |
| MPR21104T | Biopharmaceutics and Pharmacokinetics | Core | 4 | Drug absorption, distribution, metabolism, excretion (ADME), Bioavailability and bioequivalence studies, Pharmacokinetic models, Drug interactions, Clinical pharmacokinetics |
| MPR21105P | Regulatory Affairs Lab - I | Lab | 2 | Drug approval document preparation, Labeling and packaging requirements, Quality management system implementation, Analytical method validation, Dossier preparation exercises |
| MPR21106T | Research Methodology and Biostatistics | Core | 4 | Research design and types, Data collection methods, Statistical hypothesis testing, Data analysis tools and software, Scientific writing and presentation |
| MPR21107L | Journal Club | Skill Enhancement | 2 | Scientific paper presentation, Critical literature review, Research communication skills, Public speaking techniques, Peer feedback and discussion |
Semester 2
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| MPR21201T | Pharmaceutical Regulatory Science - II | Core | 4 | Medical device regulations, Cosmetic product regulations, Biologics and biosimilar regulations, Veterinary product regulations, Global harmonization initiatives |
| MPR21202T | Intellectual Property Rights | Core | 4 | Patent law and procedures, Copyrights and trademarks, Industrial designs and geographical indications, Patent filing and prosecution, Intellectual property management |
| MPR21203T | Pharmacovigilance | Core | 4 | Adverse Drug Reaction (ADR) detection, Causality assessment, Pharmacovigilance databases, Signal management, Risk management plans |
| MPR21204T | Drug Discovery and Development | Core | 4 | Drug target identification, Lead discovery and optimization, Preclinical development studies, Clinical development phases, New Drug Application (NDA) submission |
| MPR21205P | Regulatory Affairs Lab - II | Lab | 2 | eCTD (electronic Common Technical Document) submissions, Post-marketing surveillance activities, Regulatory audits and inspections, Change control procedures, Complaint handling and recall management |
| MPR21206T | Project Management | Core | 4 | Project initiation and planning, Project execution strategies, Monitoring and controlling project progress, Project team management, Risk assessment and mitigation |
| MPR21207L | Journal Club | Skill Enhancement | 2 | Advanced literature review, Seminar presentations, Scientific debate and critical analysis, Research communication strategies, Preparation for conference presentations |
Semester 3
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| MPR21301E | Elective - I (Example: Pharma Business Management) | Elective | 3 | Business strategy in pharmaceuticals, Pharmaceutical marketing management, Financial management in pharma industry, Human resources management, Supply chain and logistics |
| MPR21302E | Elective - II (Example: Clinical Research Regulations) | Elective | 3 | Regulatory landscape of clinical trials, ICH-GCP principles in practice, Ethics Committee functioning, Investigator obligations and responsibilities, Data integrity in clinical studies |
| MPR21303R | Research Work (Phase I) | Project | 10 | Research proposal writing, Extensive literature review, Experimental design formulation, Data collection methodology, Preliminary data analysis |
| MPR21304L | Journal Club | Skill Enhancement | 2 | Advanced critical appraisal of research, Scientific presentation skills, Research communication to diverse audiences, Peer feedback and refinement, Publication ethics and standards |
Semester 4
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| MPR21401R | Research Work (Phase II) | Project | 16 | Advanced experimental work and execution, Data interpretation and statistical analysis, Thesis writing and documentation, Manuscript preparation for publication, Viva-voce examination and defense |
