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Regulatory Affairs Fellowship Program at Johns Hopkins, Baltimore Maryland

Posted by on Monday, September 10, 2018 in Workshops and Seminars .

Regulatory Affairs Fellowship Program at Johns Hopkins

The Professional Development and Career Office at Johns Hopkins University School of Medicine has invited the BRET Office of Career Development to nominate a Vanderbilt biomedical trainee to attend this all expenses-paid workshop supported by a 2017 Career Guidance Award from the Burroughs Wellcome Foundation.  It will take place at Johns Hopkins in Baltimore, Maryland this fall, followed by twelve webinar-based lunch and learn sessions.

Part I

  • When: Saturday November 17th and Sunday November 18th from 9:00 am to 5:00 pm
  • Where: Johns Hopkins Preclinical Teaching Building Room 113

Breakfast and Lunch will be provided

​The program is limited to 15 participants​.  We ask only those who are confident they are interested in a career at FDA or in regulatory affairs in the biotech industry apply.

​The program will be led by Linda Bowen, a Regulatory Affairs Professional with over 25 years experience.  Linda is also an Assistant Professor at Temple University in their Masters in Regulatory Affairs Program.


  • Careers in Regulatory Affairs and Strategy and the Role of the Regulatory Affairs Professional
  • US Regulatory Basics
  • FDA Law and Regulation
  • Clinical Basics
  • Pharmaceuticals, Lifecycle, Regulation and Processes
  • Chemistry, Manufacturing and Controls
  • Pharmacovigilance
  • Regulation of Generic Drugs
  • Adapting an academic CV to a regulatory affairs resume

Part II
The weekend training will be followed by twelve lunch and learns with FDA professionals from various agencies.  The Regulatory Affairs fellows can participate remotely via teleconference for these sessions.  One session features an HR representative who will provide tips on applying to the FDA and the writing requirement required in PHASE II of the application process.

Participants will receive the Regulatory Affairs Professional Society Handbook and membership to their Professional Society

If you would like to learn more about a career in regulatory affairs, please see the attached Regulatory Affairs handout developed by the Johns Hopkins Professional Development and Career Office and Vanderbilt University’s Office of Career Development Beyond the Lab video series.

Applications due by midnight, Wednesday, October 12, 2018  CORRECTION! Wednesday, Oct 10, 2018!

  • Fill out the following application form found here: (
  • Submit a resume highlighting academic accomplishments and other experiences relevant to this event.
  • Submit a cover letter with an explanation of why you are interested in this program to Ashley Brady at  (Please submit documents as pdfs with your last name_JHRegulatory Affairs_Fall 2018  in the file name and with subject line: JH Regulatory Affairs_Fall 2018)

Eligibility requirements
1. Applicants must be a current Vanderbilt University graduate student or postdoctoral fellow

2. PhD students who entered graduate school through the IGP, QCB, CPB, MSTP, or IMSD must have  passed their qualifying exams before the application deadline. (preference will be given to postdocs and graduate students in their 4th-6th+ years)


Please contact Ashley Brady if you have any questions: