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Biopharmaceutical Domestic Regulatory Affairs, Postgraduate Certificate

  • Application Deadline
  • 12 months
    Duration
University rank #344 (QS) Online
The Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs prepares students to enter the field as regulatory affairs professionals.

About

As biotechnology and pharmaceutical companies rapidly seek federal approval for products, demand is growing for qualified regulatory affairs professionals. The Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs is designed to provide students with a greater understanding of biopharmaceutical product regulation and the industry's evolving compliance requirements in the US.

Scientists developing new products and legal experts guiding them through the FDA approval process will benefit from regulatory affairs training. The program will also prepare students to assure compliance, reduce costs, and improve techniques governing acquisition and measurement. Students will also develop a vocabulary of over 750 acronyms and technical/regulatory words to which the FDA has applied its own distinctive meaning.

Programme Structure

Courses include:

  • Biologics Development: A QA/Regulatory Overview
  • New Drug Development: A QA/Regulatory Overview
  • Medical Device Development: A QA/Regulatory Overview
  • Food, Drug, and Medical Device Law: Topics and Cases
  • Strategic Planning and Project Management for Regulatory Affairs Professionals in Domestic and International Markets
  • Combination Products and Convergence
  • Safety Sciences 1: Introduction to Safety and Surveillance for Drugs, Biologics, and Medical Devices in the U.S. and Abroad
  • Food and Drug Administration: Creation, Behavior, and Regulatory Culture
  • Medical, Social, and Financial Dimensions of Orphan Drugs
  • Biomedical Product Development: From Biotech to Boardroom to Market
  • Regulatory Writing: Medical Device Submissions
  • Regulatory Writing: New Drug Applications

Detailed Programme Facts

  • Programme intensity Full-time
    • Full-time duration 12 months
  • Credits
    16 credits hours alternative credits
  • Languages
    • English
  • Delivery mode
    Online

English Language Requirements

  • Minimum required score:

    6.5

    The IELTS – or the International English Language Test System – tests your English-language abilities (writing, listening, speaking, and reading) on a scale of 1.00–9.00. The minimum IELTS score requirement refers to which Overall Band Score you received, which is your combined average score. Read more about IELTS.

    Schedule IELTS
  • Minimum required score:

    79

    The TOEFL iBT ® measures your English-language abilities in an academic setting. The test has four sections (reading, listening, speaking, and writing), each with a score range of 0-30, for a total score range of 0-120. Read more about TOEFL iBT ®.

    Schedule TOEFL®
  • Minimum required score:

    53

    PTE Academic (Pearson Test of English Academic) is a language test that enables students to demonstrate their writing, listening, speaking, and reading skills when applying to study in English. Delivered and marked by computer, it reports on a scale between 10 and 90.

General Requirements

  • Online application 
  • Statement of purpose (500-1000 words)
  • Professional resumé
  • Unofficial undergraduate transcripts
  • Two letters of recommendation
  • English Language Proficiency Proof

Getting a Student Visa

This is an online programme. You can attend from the comfort of your chair! So you don't need a student visa!

Tuition Fee

  • International

    11484 USD/year
    Tuition Fee
    Based on the original amount of 11488 USD for the full programme and a duration of 12 months.
  • National

    11484 USD/year
    Tuition Fee
    Based on the original amount of 11488 USD for the full programme and a duration of 12 months.
We've labeled the tuition fee that applies to you because we think you are from and prefer over other currencies.

Funding

Many students, both full- and part-time, will qualify for some form of financial aid or scholarships. We encourage all students who apply for admission to seek out these opportunities. We hope to assist you in reaching your goals to become a student at Northeastern University.

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Fast Track Your Education Scholarship

The Fast Track Your Education Scholarship is an opportunity for students who have been in the workforce for five or more years, have an associate degree or an equivalent of 60 semester hours (or 80 quarter hours) of transferrable credits, and are seeking to complete their bachelor’s degree in a fast-track format at the College of Professional Studies at Northeastern University.

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The Mass Bay Community College Scholarship is a scholarship opportunity for associate degree graduates from Mass Bay Community College who are seeking to complete their bachelor’s degrees at the College of Professional Studies (CPS) at Northeastern University.

Professional Information Technology Scholarship

The Professional Information Technology Scholarship was created to support bachelor’s degree-seeking students who intend to complete their degree in Information Technology and are currently working or seeking a career in the field.

Roxbury Community College Scholarship

The Roxbury Community College Scholarship is a scholarship opportunity for associate degree graduates from Roxbury Community College who are seeking to complete their bachelor’s degree at the College of Professional Studies (CPS) at Northeastern University.

Urban Education Community College Scholarship

The Urban Education Community College Scholarship was created to support bachelor’s degree-seeking students who intend to become teachers in urban schools.

Working Professionals Education Advancement Scholarship

The Working Professionals Education Advancement Scholarship is a scholarship opportunity for professionals who have been in the workforce for 10 or more years and are seeking to complete their bachelor’s degree at the College of Professional Studies at Northeastern University.

Studyportals Tip: Students can search online for independent or external scholarships that can help fund their studies. Check the scholarships to see whether you are eligible to apply. Many scholarships are either merit-based or needs-based.

The Global Study Awards: get funded with up to £10,000 to study abroad

Together with the ISIC Association and British Council IELTS, Studyportals offers you the chance to receive up to £10000 to expand your horizon and study abroad. We want to ultimately encourage you to study abroad in order to experience and explore new countries, cultures and languages.

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