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M-PHARM in Pharmaceutical Regulatory Affairs at SRM Institute of Science and Technology
Chengalpattu, Tamil Nadu
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About the Specialization
What is Pharmaceutical Regulatory Affairs at SRM Institute of Science and Technology Chengalpattu?
This Pharmaceutical Regulatory Affairs program at SRM Institute of Science and Technology focuses on the intricate framework governing drug development, manufacturing, and marketing in India and globally. It equips students with a deep understanding of regulatory guidelines, dossier preparation, quality assurance, and intellectual property. The program is vital for the burgeoning Indian pharmaceutical sector, which is a major global supplier of generics and vaccines, demanding a strong regulatory workforce. This specialization aims to bridge the gap between scientific innovation and regulatory compliance.
Who Should Apply?
This program is ideal for Bachelor of Pharmacy graduates seeking entry into the regulatory domain of pharmaceutical and healthcare industries. It also caters to working professionals in pharma R&D, manufacturing, or quality control who aim to transition into or advance their careers in regulatory affairs. Aspiring regulatory professionals, compliance officers, and quality assurance managers will find this program crucial for developing expertise in navigating complex regulatory landscapes.
Why Choose This Course?
Graduates of this program can expect diverse career paths in India as Regulatory Affairs Managers, Clinical Research Associates, Quality Assurance Executives, or Intellectual Property Specialists. Entry-level salaries typically range from INR 3.5 to 6 lakhs per annum, with experienced professionals earning significantly more, up to INR 15-25 lakhs annually in leading Indian and multinational pharma companies. The program prepares students for roles in CDSCO, state drug control bodies, and private sector firms, aligning with national and international professional certifications.
Student Success Practices
Foundation Stage
Master Core Regulatory Concepts- (Semester 1-2)
Dedicate significant time to thoroughly understand the foundational principles of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and national/international regulatory frameworks like CDSCO, USFDA, and EMA. Utilize textbooks, official guidelines, and online resources to build a strong theoretical base for the subsequent specialized subjects.
Tools & Resources
ICH Guidelines website, CDSCO website, USFDA official guidance documents, NPTEL lectures on Quality Assurance
Career Connection
A robust understanding of these core concepts is fundamental for any role in regulatory affairs, ensuring you can correctly interpret and apply regulations in industry settings, which is highly valued during placements.
Develop Data Analysis and Research Skills- (Semester 1-2)
Actively engage with Research Methodology and Biostatistics courses, both theory and practical. Focus on mastering statistical software like R, SPSS, or basic Excel functions for data interpretation. Participate in journal clubs to critically analyze research papers and present findings, enhancing both analytical and presentation skills.
Tools & Resources
SPSS/R software tutorials, Coursera/edX courses on Biostatistics, SRM IST library for scientific journals
Career Connection
Proficiency in data analysis and research is crucial for understanding clinical trial data, regulatory submissions, and pharmacovigilance reports, making you a more versatile candidate for research and regulatory roles.
Engage in Pharmaceutical Quality Practices- (Semester 1-2)
Take initiative in laboratory practicals related to Quality Assurance. Learn to prepare and maintain standard operating procedures (SOPs), conduct quality control tests, and understand documentation requirements. Seek opportunities to visit pharmaceutical manufacturing units or quality control labs if possible, to observe real-world application of GMP.
Tools & Resources
Lab manuals and protocols, Industry visits (organized by department or self-initiated), Online webinars on QA/QC
Career Connection
Hands-on experience with quality assurance principles directly translates to roles in QA/QC departments, regulatory compliance, and audit teams, providing a practical edge during job interviews.
Intermediate Stage
Master Dossier Preparation and eCTD- (Semester 2-3)
Focus intently on subjects covering regulatory submissions, dossier compilation (CTD/eCTD format), and post-approval changes. Seek out practical training or workshops on eCTD software. Practice compiling mock dossiers for different regulatory agencies to understand the complexities and nuances of each section.
Tools & Resources
eCTD software demos (if available), ICH M4 guidelines, Pharmaceutical industry training programs
Career Connection
Proficiency in eCTD compilation is a high-demand skill in the pharmaceutical industry, making you exceptionally valuable for roles in regulatory operations and submissions, leading to better placement opportunities.
Network with Industry Professionals- (Semester 2-3)
Actively participate in departmental seminars, industry conferences, and webinars. Connect with guest speakers, faculty members with industry experience, and alumni working in regulatory affairs. Utilize platforms like LinkedIn to build a professional network. These connections can lead to mentorship, internship opportunities, and insights into industry trends.
Tools & Resources
LinkedIn, Industry events (e.g., CPhI, India Pharma Week), Alumni association events
Career Connection
Networking is paramount for job searching and career growth in India. Strong professional connections can open doors to unadvertised positions, provide valuable career advice, and help you understand specific company cultures.
Engage in Applied Regulatory Research- (Semester 2-3)
Choose a research project in Semester 2 and 3 that focuses on a current regulatory challenge or a specific aspect of pharmaceutical regulatory affairs, perhaps comparing regulations across different regions or studying the impact of new guidelines. This applied research helps in developing problem-solving skills and a deep understanding of a niche area.
Tools & Resources
SRM IST research labs, Academic journals (e.g., Journal of Pharmaceutical Regulatory Affairs), Government regulatory databases
Career Connection
Undertaking a relevant research project showcases your ability to contribute to the field, making your profile stand out to recruiters for R&D, regulatory science, or policy-making roles.
Advanced Stage
Intensive Thesis Work and Publication- (Semester 4)
Devote maximum effort to your final research project and thesis submission in Semester 4. Aim for high-quality research that can potentially be published in a peer-reviewed journal. Seek regular feedback from your guide and refine your writing and presentation skills for your viva voce. This demonstrates strong academic and research capabilities.
Tools & Resources
Mendeley/Zotero for referencing, Grammarly for writing refinement, Researchgate for identifying journals
Career Connection
A well-executed thesis and potential publication enhance your credentials significantly for advanced roles, academic positions, or even further doctoral studies, providing a strong talking point in interviews.
Prepare for Regulatory Certifications- (Semester 3-4)
Alongside your academic studies, consider preparing for professional certifications relevant to regulatory affairs, such as those offered by organizations like Regulatory Affairs Professionals Society (RAPS) or local industry bodies. While not mandatory, these certifications demonstrate commitment and specialized knowledge to potential employers.
Tools & Resources
RAPS website for certification details, Online preparatory courses, Study groups
Career Connection
Obtaining professional certifications can significantly boost your employability and demonstrate proactive professional development, giving you a competitive edge in the Indian job market.
Simulate Mock Interviews and Placements- (Semester 3-4)
Actively participate in mock interviews and placement preparation workshops organized by SRM IST''''s career services. Focus on articulating your knowledge of regulatory affairs, discussing your thesis work, and demonstrating soft skills. Practice answering scenario-based questions relevant to regulatory compliance and ethics.
Tools & Resources
Career guidance cells, Online interview practice platforms, Peer role-playing exercises
Career Connection
Effective interview skills are critical for converting opportunities into job offers. This practice ensures you are confident, articulate, and well-prepared to secure placements in top pharmaceutical companies and regulatory bodies.
Program Structure and Curriculum
Eligibility:
- A candidate who has passed B.Pharm. degree examination from an AICTE and PCI approved institution with minimum 50% marks in aggregate or any other qualification approved by PCI as equivalent to B.Pharm. Candidates should be qualified in GPAT/PGCET/any other equivalent 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 |
|---|---|---|---|---|
| MPRA101T | Research Methodology and Biostatistics | Core | 4 | Research design and methods, Data collection and sampling, Statistical analysis techniques, Hypothesis testing and ANOVA, Regression and correlation analysis, Epidemiological study designs |
| MPRA102T | Good Clinical Research Practices | Core | 4 | Principles of GCP, Phases of clinical trials, Ethics in clinical research, Regulatory requirements for clinical trials, Informed consent process, Audits and inspections in clinical trials |
| MPRA103T | Pharmaceutical Quality Assurance and Management | Core | 4 | Quality systems and philosophies, Good Manufacturing Practices (GMP), ICH Quality guidelines, Quality control and analytical methods, Documentation and record keeping, Quality audits and self-inspections |
| MPRA104T | Concepts of Pharmaceutical Regulatory Affairs | Core | 4 | Overview of drug regulatory agencies (India, US, EU), Drug development and approval process, Dossier preparation and CTD format, Post-market surveillance and pharmacovigilance, Intellectual Property Rights in pharma, Global regulatory harmonization |
| MPRA105P | Regulatory Affairs and Quality Assurance Practical | Practical | 4 | Preparation of GMP documentation, Quality control tests for pharmaceuticals, Stability study design and execution, Mock regulatory document compilation, Audit checklist preparation, Deviation and CAPA procedures |
| MPRA106P | Research Methodology and Biostatistics Practical | Practical | 4 | Application of statistical software, Data analysis and interpretation, Experimental design for pharma studies, ANOVA and t-test applications, Bioavailability data analysis, Presentation of research findings |
| MPRA107S | Seminar/Journal Club | Skill | 1 | Scientific literature review, Presentation skill development, Critical analysis of research papers, Discussion of current topics, Preparation of technical reports, Peer learning and feedback |
Semester 2
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| MPRA201T | Regulatory Aspects of Pharmaceuticals and Biologics | Core | 4 | USFDA regulations for drugs and biologics, European Medicines Agency (EMA) guidelines, Indian regulatory landscape (CDSCO), Regulation of medical devices, Biosimilars and their regulatory pathways, Global regulatory submission strategies |
| MPRA202T | Quality Risk Management and cGMP | Core | 4 | ICH Q9: Quality Risk Management principles, Risk assessment tools (FMEA, HAZOP), Quality by Design (QbD) concepts, Process validation and cleaning validation, Current Good Manufacturing Practices (cGMP), Data integrity and compliance |
| MPRA203T | Intellectual Property Rights and Regulatory Strategies | Core | 4 | Patent law and patent application process, Trademark, copyright, and trade secrets, Regulatory strategies for generic drugs, Data exclusivity and market exclusivity, Freedom to Operate (FTO) analysis, Global IP protection and enforcement |
| MPRA204T | Regulatory Inspections and Audits | Core | 4 | Types of regulatory inspections, Preparation for audits and inspections, Responding to inspection findings (483s, warning letters), Compliance programs and enforcement actions, Root cause analysis and corrective actions, Internal and external audit management |
| MPRA205P | Advanced Regulatory Affairs Practical | Practical | 4 | eCTD compilation using software, Handling post-approval changes, Management of deviations and non-conformances, Product recall procedures, Mock regulatory agency inspections, Complaint handling and adverse event reporting |
| MPRA206S | Seminar/Journal Club | Skill | 1 | Review of advanced regulatory topics, Analysis of recent regulatory changes, Case studies in regulatory affairs, Industry trends and outlook, Policy analysis and recommendations, Advanced communication skills |
| MPRA207S | Research Work (Project) | Project | 5 | Detailed literature review, Formulation of research proposal, Experimental design and methodology, Data collection and preliminary analysis, Project planning and management, Initial thesis writing and report generation |
Semester 3
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| MPRA301S | Research Work (Project) | Project | 14 | Conducting experimental work, Advanced data analysis and interpretation, Troubleshooting and problem-solving, Scientific writing and manuscript preparation, Ethical considerations in research, Regular progress reporting and presentations |
| MPRA302S | Pre-registration Seminar | Seminar | 1 | Comprehensive research progress presentation, Incorporating feedback for improvement, Structuring of thesis and abstract writing, Preparation for viva voce examination, Refinement of research methodology, Addressing identified challenges in research |
Semester 4
| Subject Code | Subject Name | Subject Type | Credits | Key Topics |
|---|---|---|---|---|
| MPRA401S | Research Work and Thesis Submission | Project | 16 | Finalization of thesis manuscript, Preparation for thesis defense (viva voce), Scientific publication strategy, Addressing all research objectives, Data validation and accuracy checks, Final presentation of research outcomes |
