Post-Baccalaureate Certificate in Regulatory Affairs for Cell and Gene Therapy

Certificate Level: Graduate
Admissions Requirements: Bachelor's degree or higher
Certificate Type: Post-Baccalaureate
Number of Credits to Completion: 14.0
Instructional Delivery: Online
Calendar Type: Semester
Expected Time to Completion: 1-2 years
Financial Aid Eligibility: Not aid eligible
Classification of Instructional Program (CIP) Code: 51.0720
Standard Occupational Classification (SOC) Code: 17-2031
 

About the Program

The Certificate in Regulatory Affairs for Cell and Gene Therapy trains leaders for this growing discipline and prepares them to bring new therapeutics to market. Students will learn how to manage everything from pre-clinical IND-enabling studies to product licensure, and on into post-approval lifecycle management, post-approval change reporting categories, accelerated approval mechanisms, managing agency inspections, ethics, CMC, and international market requirements for cell and gene regulatory affairs.

Admission Requirements

Post-college applicants must have completed a four-year degree program. An undergraduate degree in science is preferred but not required; a minimum cumulative grade point average (GPA) of 3.0 is strongly preferred.

Applicants must also submit the following requirements for consideration:

• Official transcripts from all colleges and universities attended
• Official test scores from graduate and professional admission exams, such as the Graduate Record Examination (GRE), Graduate Management Admission Test (GMAT), Law School Admission Test (LSAT), or Medical College Admission Test (MCAT), are optional but highly desirable
• References from at least three instructors or professionals
• Three letters of recommendation are required.

If you received your degree within the last five years, it is strongly recommended that at least one letter of recommendation be provided by someone familiar with your academic qualifications and potential (e.g., your undergraduate advisor, a course instructor or your research mentor). If you are requesting a letter from someone at your place of employment, the recommendation should be provided by a supervisor (or another more senior manager) with direct knowledge of your work and should address your scientific aptitude as well as your work ethic.

International applicants (non-United States citizens) must meet the same requirements for admission as students from the United States. Applicants whose native language is not English must demonstrate the ability to speak, write and understand the English language by submitting an acceptable score on the Test of English as a Foreign Language (TOEFL). IELTS scores may be submitted in lieu of TOEFL scores. An evaluation by World Education Services (WES) is required for transcripts from institutions outside the United States.

TOEFL score needs to be at least 90 with at least a 27 in both the reading and writing sections.
IELTS score needs to be above 7.
Certain visa types do not permit individuals to enroll in online or hybrid programs. Foreign applicants should check with their visa sponsors for eligibility. Drexel University cannot sponsor F-1 or J-1 visas for individuals interested in online, hybrid or part-time programs.

Online applications are accepted year-round for consideration for either fall or spring admission. Students may defer admission by one year. All admission decisions are made at the College of Medicine.

Program Requirements

Sample Plan of Study

Fall Start, Part-Time

Spring Start, Part-Time

Note: Only spring semester is more than the 4.5-credit minimum required (considered half-time status) of graduate programs to be considered financial aid eligible. As a result, aid will only be disbursed to students this term.

Summer Start, Part-Time

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Note: First Year Summer is less than the 4.5-credit minimum required (considered half-time status) of graduate programs to be considered financial aid eligible. As a result, aid will not be disbursed to students this term.

Additional Information

For questions about the curriculum and program goals, please contact Program Director Sujata Bhatia, MD, PhD, at skb322@drexel.edu.

For questions about how to apply to the program, please contact an enrollment counselor at duonline@drexel.edu.

For information regarding financial aid, please visit Drexel Central.