M.S. in Clinical Investigation and Development
The M.S. in Clinical Investigation and Development is a 36-credit master's degree p...
M.S. in Regulatory Sciences
Boston
INTAKE: Jan & Sept
Program Overview
The M.S. in Regulatory Sciences is a 36-credit, full-time program typically completed in two years, offered on the Boston campus. It is designed for individuals seeking rigorous academic training in the principles and applications of regulatory science, quality assurance, and quality control within the healthcare product lifecycle. The program aims to equip graduates with the credentials and confidence to assume significant roles in federal or state healthcare regulatory agencies, clinical research organizations (CROs), managed care institutions, and other health-related organizations involved in the development, assessment, and approval of FDA-regulated products. It is particularly valuable for those with a PharmD degree or a strong scientific background.
Curriculum: The curriculum for the M.S. in Regulatory Sciences is comprehensive, focusing on the scientific and technical aspects of regulatory compliance and product quality. Core courses include "Fundamentals of Pharmaceutical Science," "Chemistry, Manufacturing, and Controls," "Active Pharmaceutical Ingredients for Regulatory Sciences," "Generic Drug and Biosimilar Development," "FDA and Regulatory Affairs," "Statistics in Clinical Research," "Protection of Human Research Subjects," "Health Epidemiology," and "Principles of Quality Assurance and Control." The program culminates in a "Capstone" experience. Elective courses allow for specialization in areas such as "Law and Health Policy of Drugs and Devices," "Development and Production of Medical Devices," "Introduction to Health Economics and Outcomes Research," or "Cosmetic and Personal Care Products," among others.
Research Focus: The M.S. in Regulatory Sciences program at MCPHS places a strong emphasis on the "science of standards" and the application of scientific principles to regulatory decision-making. While it is not a traditional bench-research degree focused on drug discovery, it trains students to apply scientific rigor in assessing the safety, efficacy, quality, and performance of drugs and devices. The curriculum includes courses like "Statistics in Clinical Research" and "Health Epidemiology," which are fundamental to understanding and interpreting data from clinical investigations and post-market surveillance. The program's focus on areas like Chemistry, Manufacturing, and Controls (CMC) and Active Pharmaceutical Ingredients underscores its scientific foundation. The Capstone experience allows students to apply their analytical and problem-solving skills to real-world regulatory science challenges.
Industry Engagement: MCPHS University is deeply integrated into the pharmaceutical, biotechnology, and medical device industries, providing substantial industry engagement for its Regulatory Sciences program. Located in a major biotech cluster, students benefit from a curriculum designed to meet pressing professional needs, with faculty often comprising executives and experts who bring practical experience and industry connections into the classroom. The program prepares graduates for roles that involve developing tools, standards, and assessments for FDA-regulated products. Opportunities for practicums (internships) are available, providing hands-on experience and valuable networking in leading companies and agencies. MCPHS's strong alumni network further facilitates career opportunities within the life sciences sector.
Global Perspective: The M.S. in Regulatory Sciences program at MCPHS inherently incorporates a global perspective, as regulatory science principles and best practices are increasingly harmonized and applied internationally. While specific courses may not explicitly state "global," the program's focus on "the latest best practices" and "innovations in the healthcare realm" implies an awareness of international standards and challenges. The pharmaceutical and medical device industries operate globally, and understanding regulations in major markets worldwide is crucial. Graduates are prepared to work with federal or state healthcare regulatory agencies, but the skills gained are universally applicable, equipping them to contribute to the global regulatory landscape and ensure the safety and efficacy of healthcare products on a worldwide scale.
Location
Boston
Score
IELTS 7
Tuition Fee
USD 27825
Postgraduate Entry Requirements
Academic Qualifications: Applicants for postgraduate programs typically require a minimum academic achievement of 70% or above in their bachelor's degree.
English Language Proficiency:
- IELTS: Overall band score of 6.5 or 7.0 with a minimum of 6.0 in each component.
- TOEFL: Overall score of 90 or higher.
- PTE: Overall score of 73 or higher.
- DET (Duolingo English Test): Minimum score of 115.
Massachusetts College of Pharmacy and Health Sciences (MCPHS) in the United States offers a variety of scholarship opportunities specifically designed for international students to help make their education more affordable and accessible. These scholarships recognize academic excellence, leadership qualities, and financial need, enabling talented students from around the world to pursue their healthcare education without financial burden.
Merit-Based Scholarships: MCPHS provides merit-based scholarships that reward outstanding academic performance. International students with strong academic records, competitive test scores, and leadership potential may qualify for these scholarships, which can cover a significant portion of tuition fees.
Need-Based Financial Aid: While limited, some need-based scholarships and financial aid options are available to international students who demonstrate financial need. Applicants must provide evidence of their financial status and submit the required documentation during the admission process.
Program-Specific Scholarships: Certain colleges and departments within MCPHS offer specialized scholarships tailored to specific health science programs such as Pharmacy, Nursing, Physician Assistant Studies, and Public Health. These scholarships often prioritize candidates pursuing high-demand healthcare fields.
International Student Scholarship Opportunities: MCPHS frequently offers dedicated international student scholarships aimed at encouraging a diverse student body. These scholarships are competitive and awarded based on academic merit, leadership, and contributions to the community.
External Scholarships and Partnerships: International students at MCPHS are encouraged to explore external scholarship programs and partnerships offered by governments, private foundations, and international organizations. The university’s financial aid office provides guidance and resources to help students identify and apply for these opportunities.
A Master of Science (M.S.) in Regulatory Sciences from Massachusetts College of Pharmacy and Health Sciences (MCPHS) positions graduates as essential contributors in the highly regulated and rapidly evolving healthcare product industries.
Regulatory Affairs Specialist: This is a foundational role where graduates are responsible for preparing and submitting regulatory documents (e.g., New Drug Applications, Investigational New Drug Applications) to health authorities like the FDA, ensuring all submissions meet stringent scientific and legal requirements. They often work for pharmaceutical, biotech, or medical device companies.
Quality Assurance (QA) Scientist/Specialist: Graduates in this role ensure that all stages of product development, manufacturing, and testing adhere to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other quality regulations. They develop and implement quality management systems and conduct audits to maintain compliance.
Quality Control (QC) Analyst/Scientist (with Regulatory Insight): While primarily involved in testing raw materials and finished products, an M.S. in Regulatory Sciences provides a deeper understanding of the regulatory implications of quality data, enabling these professionals to ensure that all testing and documentation comply with regulatory standards.
Chemistry, Manufacturing, and Controls (CMC) Specialist: This specialized role focuses on the regulatory aspects of a product's chemistry, manufacturing, and controls information. Graduates ensure that the manufacturing process is robust and reproducible, and that all related data are accurately presented in regulatory submissions.
Regulatory Operations Specialist: These professionals manage the electronic submission of regulatory documents, ensuring that all data and information are organized, formatted, and submitted correctly to regulatory agencies. They are critical for efficient and compliant submission processes.
Medical Device Regulatory Affairs Professional: Given the specific regulations for medical devices, graduates can specialize in navigating their unique development, testing, approval, and post-market surveillance pathways, ensuring compliance with standards like ISO 13485, FDA's 510(k), or EU MDR.
Regulatory Compliance Auditor: Graduates can work for pharmaceutical companies, CROs, or consulting firms to conduct internal and external audits of clinical trials, manufacturing facilities, and quality systems to ensure ongoing adherence to regulatory guidelines and identify areas for improvement.
Post-Market Surveillance Specialist: These professionals monitor the safety and performance of drugs and devices after they have been approved and marketed. They collect and analyze adverse event data, manage product complaints, and ensure timely reporting to regulatory agencies.
Regulatory Project Manager: These managers oversee regulatory projects from inception to completion, coordinating cross-functional teams, managing timelines and budgets, and ensuring that all regulatory deliverables for product development or compliance initiatives are met.
Regulatory Affairs Consultant: Graduates can leverage their expertise to advise multiple clients (e.g., small biotech startups, established pharmaceutical companies) on regulatory strategy, product development pathways, compliance issues, and market entry strategies across various therapeutic areas.
