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Overview
The Department of Pharmaceutical Regulatory Affairs and Management (Formerly called as Department of Pharmacy Management), Manipal College of Pharmaceutical Sciences (MCOPS), Manipal Academy of Higher Education (MAHE), Manipal is one of its kind. The Postgraduate Programme in Pharmaceutical Regulatory Affairs at MCOPS, Manipal, is designed to prepare students for the dynamic and highly regulated global pharmaceutical sector. This programme equips graduates with specialized knowledge of regulatory requirements, quality systems, and management practices essential for the development, approval, and marketing of pharmaceutical products. With a curriculum that integrates regulatory sciences, pharmaceutical policy, quality assurance, and management principles, the course bridges academic learning with real-world industry practices. Students benefit from expert faculty, interactive learning modules, case studies, and exposure to the latest international regulatory guidelines. Graduates are well-positioned for careers in regulatory affairs, clinical research, pharmaceutical management, compliance, and quality assurance across academia, industry, and government agencies. The programme also provides a strong foundation for those aspiring to pursue doctoral studies and research in regulatory sciences.
Why Choose Pharmaceutical Regulatory Affairs as a Career?
Pharmaceutical Regulatory Affairs is a rapidly growing field that plays a vital role in ensuring the safety, efficacy, and quality of medicines worldwide. With the pharmaceutical industry expanding globally, the demand for skilled regulatory professionals is at an all-time high.
Click to view Regulations for MPharm Pharmaceutical Regulatory Affairs programme
There are a wide variety of careers in the Pharmaceutical Regulatory Affairs field and carry titles such as:
- Regulatory affairs executive
- Regulatory affairs specialist
- Regulatory affairs manager
- Compliance specialist
- Food safety inspector
- Clinical Research Associate
- Scientific Communications
- Medical Writing
- Regulatory Prototyping
- Drug Safety Associate
- Pharmacovigilance
- Business Analyst
- Business Development Officer
- Doctoral degree
- Academia
Core competencies and consultancy services offered by the department in various fields include:
- Global Pharmaceutical Regulatory Affairs
- Documentation & Dossier Preparation
- Quality & Compliance
- Clinical & Safety Regulations
- Medical Device and Cosmetic Regulations
- Data Integrity
- Intellectual Property Rights
- Pharmaceutical Sales and Marketing
- Entrepreneurship development
- Professional Skill Development
- Health Economics and Outcomes Research
Key Features
- Finest infrastructure with sophisticated and well-equipped classrooms
- Licensed e-CTD Software
- Well qualified dedicated faculties with PhD
- Industry sponsored projects to provide rich experience to research scholars and MPharm students.
- Placement assistance
- Consultancy Services: Business analytics, Regulatory affairs, Intellectual Property Rights, Market research.
Industry Collaborations
- Wockhardt Ltd. Aurangabad
- Cipla Limited, Goa
- Novartis
- Gilead Sciences
- Viatris Inc
Within Manipal Academy of Higher Education:
- Kasturba Medical College, Manipal
- Manipal Institute of Technology, Manipal
Manipal School of Commerce and Economics
Program Educational Objectives (PEOs)
Faculty
The department has highly qualified faculty members with a doctoral degree and aims at transforming the lives of students entering the portals of the Department of Pharmacy Management at MCOPS, MAHE.
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Guest Lectures, eCTD training and Consultancy Services
Business analytics, Regulatory affairs, Industry professional guest talks, Hands on training of eCTD Software for product dossier submission, Intellectual Property Rights & Market research.
Placement & Facility
Second year live industry project with stipend followed by industry placement
Faculty
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Facilities and Services
Department of Pharmaceutical Regulatory Affairs and Management is pioneer in pharmacy mangment education in India
Research Facilities
Best in class business analytics facilities with industry expertise
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Activities
Departmental activities, programs, MAHE Research Day Celeberations
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Staff and Students
Staff with industry experience bring out the best from students
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National Science Day
Exhibition of Pharmaceutical Regulatory Affairs during National Science Day every year
Department Library
Libraries give students access to study resources, digital and print
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Services
Industry oriented services in Training, Annual Industry Visit, IPR, Marketing, Entrepreneurship and Analytics
Research & Publications
The Department includes core research areas such as the development and recommendation of robust regulatory models for Complex Generics, Medical Devices, Veterinary Drugs, Herbal Drugs, Spurious (Counterfeit) Drugs, Cosmeceuticals, Nutraceuticals, and Clinical Research. Faculty members have collaboration with reputed national and international academic and research institutes. Faculty and students have published their outstanding research in reputed journals, such as: The Lancet, Therapeutic Innovation & Regulatory Science, Indian Journal of Medical Research, Current Science, Expert Review of Medical Devices etc.
Testimonials
My time pursuing a Master's in Regulatory Affairs at Manipal College of Pharmaceutical Sciences (MCOPS) transformed my professional trajectory in ways I couldn't have imagined. What truly set MCOPS apart was the faculty's industry experience and dedication to student success. Their mentorship extended beyond the classroom, providing invaluable insights into regulatory strategies and emerging global trends. Since graduating, I've advanced rapidly in my career, securing positions with increasing responsibility in regulatory affairs. The network I built at MCOPS has proven invaluable throughout my career. For students considering a career in pharmaceutical regulatory affairs, MCOPS provides not just education, but a transformative experience that opens doors to exceptional opportunities in this critical and evolving field.
Mr. Teekanam Jagadeesh
Student
My time at MCOPS, specializing in Pharmaceutical Regulatory Affairs, has been one of the most defining phases of my life. Beyond the academic knowledge, the program instilled in me adaptability, problem-solving, and resilience, the qualities that continue to guide me in every step of my career. Even though my journey has taken me from Regulatory Affairs into the world of Data Engineering, the skills and perspective I developed at MCOPS remain my strongest foundation. Looking back, I cherish those years not just for the curriculum, but for how deeply they shaped the way I approach challenges and opportunities in life.
Sandeesha Lunawat
M.Pharm Pharmaceutical Regulatory Affairs (2017 – 2019)
Junior Regulatory Affairs Specialist, Covance India
My time at MCOPs has been nothing short of transformative. As I reflect on my years here, I realize how deeply this institution and department has shaped both my personal and professional growth. From the very first day, the warm and inclusive atmosphere of the college made me feel at home. The faculty members, experts in Pharmaceutical Regulatory Affairs have been not only knowledgeable but also incredibly approachable. Their constant encouragement, support, and genuine interest in my progress helped me navigate through the rigorous curriculum with confidence. The curriculum is meticulously designed to ensure that students are well-prepared to excel in the ever-evolving field of pharmacy. As I stand at the threshold of my professional journey, I feel confident and prepared, thanks to the strong foundation built here. I will forever carry the values, knowledge, and experiences from Manipal with me as I move forward in my career and life.
Aishwarya-Surampuri (Batch 2018-2020)
Regulatory specialist, Sandoz
Pursuing Masters from MCOPS in Pharmaceutical Regulatory Affairs department was a great experience for me. The curriculum was very well planned with an optimum balance of theory and practical knowledge. The highlight of the program was the various guest lecturers which helped us to gain industry exposure. Our faculty members were very approachable and supported us throughout the journey. The Department provided us with an excellent learning environment with many growth opportunities. Overall, I am grateful to be a part of this department which helped me in equipping the skills and confidence to move forward successfully!
Ms. Nikita Khule (Batch 2021-2023)
Regulatory Specialist - GSK