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Northeastern University recently hosted top researchers, advocates, and industry experts for 
an engaging discussion about the future of biopharmaceuticals, considered by many to be the cutting edge of medical science in America. Dr. Graham Jones, associate director of the Barnett Institute and chair of the Department of Chemistry and Chemical Biology, presented at the event. Dr. Jones launched the nation's first Professional Science Master’s Program in Regulatory Science at Northeastern last year. Read more.
The fastest growing sector in the biotechnology field is in the regulatory science of biopharmaceuticals. Over the past two years we have been working closely with the US Food and Drug Administration (FDA) and the biotechnology industry, and as a result launched an independent PSM in Regulatory Science of Biopharmaceuticals. The job market in this field is set to become significant, and both the regulators and industry are seeking motivated individuals who combine practical laboratory skills in protein expression, purification and characterization with business and legal skills – all ingredients of our new PSM.
Regulatory science encompasses the scientific and technological basis for production, regulatory approval, and subsequent monitoring of biopharmaceutical substances. The discipline is distinctive from the research and development that supports drug discovery and development and is different from regulatory affairs which is concerned with the development and enforcement of regulations through clearly defined administrative protocols. Northeastern's College of Professional Studies offers a Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices. For information go to www.cps.neu.edu/degree-programs/graduate/masters-degrees/masters-regulatory-affairs.php.
Educational Objectives
Our main educational objective for students is to equip them with core competencies in protein and carbohydrate chemistry, bioprocess engineering, immunology and immunogenicity, and analysis and characterization methodologies augmented by technical knowledge of regulatory issues, business, and communications. Our program aims to prepare students for highly valued positions in the biotechnology and pharmaceutical industries as well as in government agencies such as the FDA.
Graduates receive an M.S. in biopharmaceutical regulatory science.
Curriculm Map for Full-time Students Entering AY12/13
Biopharmaceutical Regulatory Science PSM (32 SH credits)
First Year
Fall Semester
CHEM5550 Introduction to Glycobiology and Glycoprotein Analysis (3 SH)
CHME5630 Biochemical Engineering (4 SH)
CHEM5500 Introduction to Regulatory Science (2 SH)
Spring Semester
CHEM5660 Analytical Biochemistry (3 SH)
CHEM5620 Protein Chemistry (3 SH)
Business Elective (3 SH)
Summer Semester
CHEM5570 Regulatory Science Applications Laboratory (4 SH)
Second Year
Fall Semester
BIOT5330 Drug Safety and Immunogenicity (3 SH)
Science Elective (3 SH)
Business Elective (3 SH)
Spring Semester
BIOT6964 Co-op Work Experience in Biotechnology (0 SH)
BIOT6411 Co-op Reflection Seminar in Biotechnology (1 SH)
Progression Requirements
Students will be required to maintain a grade-point average (GPA) of 3.00 (on a 4.00 scale) or better to remain in good standing in the Program. Student performance will be reviewed annually. Those students with GPAs below 3.00 will be placed on probation for one semester, during which they will be expected to return to good standing. Failure to raise the GPA to 3.00 will be grounds for dismissal from the program.
Students are expected to have a minimum GPA of 3.00 and be cleared by the Graduate
Co-op Coordinator prior to performing the internship.
Students will be admitted in both the Fall 2012 and Spring 2013 semesters. The deadline for Fall 2012 for all applicants needing a visa (international) was May 1, 2012. The deadline for Fall 2012 for all other applicants is August 1, 2012. All required material must be postmarked and the application package must be complete by the deadline. Complete applications will be reviewed as they are received.
The deadline for Spring 2013 for all applicants needing a visa (international) is October 1, 2012. The deadline for Spring 2013 for all other applicants is December 1, 2013. All required material must be postmarked and the application package must be complete by the deadline.
Applications to the Professional Master of Science (PSM) in Biopharmaceutical Regulatory Science are processed through the College of Arts and Sciences Graduate Admissions Office and all pieces of the application package must be submitted to that office.
Admissions Requirements
- Pre-requisites - applicants to the Biopharmaceutical Regulatory Science PSM Program must have a baccalaureate (bachelor's) degree in biology, chemistry, chemical or biochemical engineering, pharmaceutical science, or a related discipline from an accredited college or university; there is not a specific requirement as to the number of years it took to obtain the degree i.e. 12+3 is acceptable for applicants from Canada, Europe, and India. Applicants must have completed at least one course in organic chemistry, molecular biology or biochemistry, genetics or physiology, and college-level calculus.
- Application (online submission only), personal goal statement, and resume
- An undergraduate GPA of 3.00 (B) or better
- Official transcripts of all undergraduate and graduate study (Northeastern transcripts must be requested by the applicant). Applicants whose transcripts are not in English must submit their official transcripts to World Education Services (WES) or Educational Credential Evaluators (ECE) for credentialing.
- Graduate Record Examination (GRE) taken within the last five years (send score reports to College of Arts and Sciences, code 3682); a minimum total score of 304 for the current version is required. A minimum toal score of 1100 or minimum quantitative score of 650 for the former version is required; a GRE Subject Test is optional
- Three letters of recommendation
- For international applicants, TOEFL (send score reports to College of Arts and Sciences, code 3682) or IELTS examination
International applicants must demonstrate proficiency in writing and speaking English with a minimal TOEFL score of 100 for the Internet-based test or minimum IELTS score of 7.0. International students residing in countries where English is not a first language are required to take the TOEFL or IELTS. International applicants residing in countries where English is a first language are required to take the TOEFL or IELTS if their native language is not English. The English language requirement is waived for international applicants who hold an undergraduate or graduate degree from a US institution.
Pace (full-time, part-time, special student)
Students in the Biopharmaceutical Regulatory Science PSM Program can enroll either on a full-time or part-time basis. Full-time students will take a minimum of eight semester hours of courses per semester. Part-time students take one or two courses. Courses are taught in the late afternoon and evening to accommodate working students. International students must be enrolled on a full-time basis.
International applicants if on an F1 (student) visa, attend full-time. Students on an H1 (work) visa must attend part-time. For more information, contact Northeastern's International Student and Scholar Institute at http://www.northeastern.edu/issi/.
Students taking courses on Special Student Status can apply up to 12 semester-hour credits towards the Regulatory Science PSM Program. Once 12 credits have been earned, a student must apply to and be accepted into the program before any further courses will count towards the degree. Special students are not eligible to enroll in the following courses: Biotechnology Applications Laboratory (IDSC7245) and Business of Biotechnology (MGMT6219). Special students are not allowed to enroll in an elective or required course from the specialized tracks without permission of a faculty advisor.
For information on how to apply for special student status, contact the Graduate School of the College of Arts and Sciences at 617-373-5990 or go to http://www.northeastern.edu/cas/graduate/special.html.
The complete package should be sent to:
Graduate School of Arts and Sciences
Northeastern University
124 Meserve Hall
360 Huntington Avenue
Boston, MA 02115-5000
USA
The Biopharmaceutical Regulatory Science PSM Program operates on a "pay-as-you-go" basis. Tuition for academic year 12/13 for Bouvé College of Health Sciences and College of Sciences courses is $1,175 per credit. College of Engineering courses are $1,270 per credit and College of Business Administration courses are $1,345 per credit. Tuition costs are expected to increase for academic year 13/14. For information on fees, consult Student Financial Services at www.northeastern.edu/financialaid/.
Partial scholarship assistance may be available for exceptional applicants. The Regulatory Science Program has no graduate assistantship positions available for students in the program.
Northeastern alumni and graduating seniors may be eligible for the Double Husky Scholarship Program. For more information, go to www.northeastern.edu/doublehusky/. Students enrolled in a PlusOne programs are not eligible for graduate financial aid administered by the Office of the Provost including Double Husky and Dean's Scholarships.
Northeastern University's Student Financial Services provides information on additional scholarship opportunities, loans, and student employment and as well as a glossary of terms at www.northeastern.edu/financialaid/. The newsletter published by Student Financial Services, The Source, is a useful resource for program applicants.
Applications to the Biopharmaceutical Regulatory Science PSM Program are to be filled out and submitted via the Apply Yourself online system only. Click on the link below to connect to the online application system.
All applications to the program are processed through the Graduate School of Arts and Sciences. All pieces of the application package, such as transcripts, must be submitted to that office.
Graduate School of Arts and Sciences
Northeastern University
124 Meserve Hall
360 Huntington Avenue
Boston, MA 02115-5000
USA
Apply Online