Career Opportunities in Regulatory Science

Internships

Genentech’s Regulatory Affairs Internship Program

  • Genentech is seeking self-motivated internship candidates with scientific backgrounds (preferably in biological sciences) who are currently enrolled (undergraduate, junior year completed, or graduate student) or within two years of most recent degree.
  • Genentech has been at the forefront of the biotechnology industry for more than 35 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer and other serious illnesses.
  • Genentech's Regulatory Affairs Internship program introduces interns to regulatory affairs and develops applied skills in functional areas across the company, such as Program Management (Oncology and Inflammation), Labeling, Commercial Regulatory, Documentation, Policy and Regulatory Intel.
  • Internships are paid positions and vary in duration from 3-12 months.
  • For more information, please email regulatoryscience@georgetown.edu.

Reagan-Udall Foundation Summer 2016 Internships

  • The Reagan-Udall Foundation for the FDA (RUF) is an independent 501(c)(3) not-for-profit organization created by Congress to advance the mission of the FDA by advancing regulatory science and research. 
  • RUF is seeking two interns for Summer 2016 to gain real-world experience at a growing nonprofit. Work would include project support to help advance the goals of RUF by assisting with several types of tasks, including project management, nonprofit administration, fundraising and development strategy, and communications.
  • To learn more about the opportunity, qualifications, and application process, visit the link above.

FDA Internships for Graduate Students

  • FDA offers regulatory science training opportunities for graduate students through the Regulatory Science Internship Program. See link above for more details about the program and application cycle deadlines.

FDA Student, Fellowship, & Senior Scientist Program

  • FDA offers undergraduate and graduate student programs, fellowships for post-graduates, and faculty and senior scientist programs. Please use the link above to find more information about programs such as the FDA ORISE Research Participation Program, Regulatory Science Student Internship Program, Center for Biologics Evaluation and Research ORISE Program, and more. 
Fellowships

ORISE Fellowship - Center for Devices and Radiological Health at the FDA

Position: ORISE Fellowship (9-18 month position)
FDA Location: Center for Devices and Radiological Health, FDA
Focus: Patient Preference Methods Development and Testing

  • Fellows will be working on a project to develop and test a method for incorporating patient preference information as an explicit means to set significance levels in clinical trials for devices to treat Parkinson’s disease. The project will involve collaborative work with FDA regulators, the Medical Device Innovation Consortium (MDIC), RTI Health Solutions, and investigators at MIT.

  • Qualified fellows will have a graduate degree (master's or higher) in progress or received in related field. Applicants should have excellent written and oral communication skills. Applicants will preferably have experience or interest in one or more of the following areas:

    • Neurologic disorders, particularly Parkinson’s disease
    • Clinical trial design
    • Biostatistics, epidemiology
    • Health economics, behavioral economics
    • Patient interaction, patient engagement, patient input, or patient preferences
    • Qualitative research
    • Patient-reported outcome measures
       
  • Contact: Applicants should prepare and send a cover letter and resume to Heather Benz, PhD, Staff Fellow, CDRH, FDA <Heather.Benz@fda.hhs.gov>

ORISE Fellowship - Office of Hematology and Oncology at the FDA

Position: ORISE Fellowship (24 month position)
FDA Location: Office of Hematology and Oncology, Center for Drug Evaluation and Research
Focus: Patient Reported Outcomes Measurement and Analysis

  • This fellowship is dedicated to PRO health care policy and research in hematology and oncology. This position is appropriate for post-doctoral fellow or master’s degree-level psychometrician, statistician, or similar background. The incumbent will have a passion for patient-reported outcome measurement and analysis. The ideal candidate would be familiar with PRO instruments, different PRO analysis methods, SAS and aggregating datasets. The fellow would work with FDA oncologists, statisticians, Clinical Outcomes Assessment (COA) staff, and policy leaders. The position is appropriate for post-doctoral fellow or master’s degree-level psychometrician, statistician, or similar background. The incumbent will have a passion for patient-reported outcome measurement and analysis. The ideal candidate would be familiar with PRO instruments, different PRO analysis methods, SAS and aggregating datasets. All applicants must be within 5 years of receiving MS/PhD.

  • Contact: Applicants should prepare and send a cover letter and resume to Paul Kluetz, MD, Associate Director, Office of Hematology and Oncology, CDER, FDA <Paul.Kluetz@fda.hhs.gov>

Georgetown University-PhRMA Fellowship in Regulatory Science 

  • Established in 2014, the Georgetown-PhRMA Fellowship in Regulatory Science provides fellows with one to two years of specialized training with access to expert faculty and scientists from Georgetown University, PhRMA, the pharmaceutical industry, and the U.S. Food and Drug Administration (FDA).
  • Fellows are awarded up to two years of salary support and research stipends, beginning with a one-year term, with possibilities for renewal after successful completion of the first year. This postgraduate fellowship will help develop researchers and scholars to reach their fullest potential in advancing innovative research to benefit public health.

FDA Tobacco Regulatory Science Fellowship

  • Application opens Tuesday, January 3, 2017, for a paid, one-year Tobacco Regulatory Science Fellowship at the Food and Drug Administration (FDA).
  • Opportunities are available in the following areas within the FDA Center for Tobacco Products (CTP): compliance and enforcement; health communication and education; management; regulations; policy; and science.
  • Launched in 2012, this regulatory science fellowship is a collaborative program between the FDA Center for Tobacco Products (CTP) and the Institute of Medicine (IOM). It is designed for mid-career professionals to gain experience and expertise to further define and develop the field of regulatory science as it relates to the regulation of tobacco products and FDA's new authorities under the Family Smoking Prevention and Tobacco Control Act.
  • The fellowship is a 12-month, multidisciplinary residential program at CTP in Maryland. Fellows will be placed in one of six offices within the CTP: Compliance and Enforcement; Health Communication and Education; Management; Policy; Regulations; or Science.
  • Fellows are expected to complete the full 12-month residential fellowship. Each fellow will be awarded up to $95,000 based on salary history. Fellows may choose to enroll in a health insurance plan through the IOM or get reimbursed for a COBRA plan. Fellows with a sponsoring institution may be compensated for fringe benefits. In addition, each fellow may be eligible to receive a relocation fund (not to exceed $10,000).

UCSF-Stanford CERSI Postdoctoral Fellowship in Regulatory Science

  • UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) is delighted to announce the inaugural Postdoctoral Fellowship in Regulatory Science and invites qualified candidates to submit applications for the 2017 cohort. The postdoctoral fellowship is an experiential program that will provide our most outstanding postdocs with unique immersion experiences in regulatory science research at UCSF or Stanford, in industry, and at the FDA. During the 2-3 year program, Fellows will receive a monthly stipend commensurate with education level and experience.
  • Individuals interested in becoming a UCSF-Stanford CERSI Postdoctoral Fellow may find more information about the program and application process on our website
  • Deadline: March 1, 2017

FDA Commissioner's Fellowship Program

  • The Fellowship Program combines rigorous graduate-level coursework with the development of a regulatory science research project. Under the guidance of an FDA senior scientist Preceptor committed to mentoring, Fellows will explore a specific aspect of FDA regulatory science.
  • Fellows also have the opportunity to contribute to FDA's review of sponsor's applications for new products or to other regulatory reviews. They work with FDA scientists to develop better research and evaluation tools and approaches, ranging from assays for chemical or pathogen detection to methods to assess clinical or health care data. Please visit the link above for more details and application information.

Graduate Medical Eduation (GME): Clinical Trial Methodology and Regulatory Science

  • This two-year fellowship is offered by the Division of Neurology Products (DNP), Food and Drug Administration (FDA), and the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), and provides training in clinical trial methodology and regulatory science. Successful applicants will participate in activities related to the planning, implementation, conduct, data and safety monitoring, and regulation of trials either conducted or funded by the NINDS, and regulated by the FDA. Application information is included within the link above. 

FDA–NIH/NCI Interagency Oncology Task Force (IOTF) Fellowship Program

  • Reference website for application details. 
Employment

FDA Seeking Digital Health Scientist (Physicians, Nurses and Interdisciplinary Engineers) Candidates

  • The Center for Devices and Radiological Health (CDRH) is seeking licensed physicians and nursing candidates as well as Interdisciplinary Engineer candidates to serve as Digital Health Scientists. This position represents an excellent career opportunity to become part of the digital health team at FDA that is charged with coordinating Digital health activities across the CDRH, providing expert advice to internal and external stakeholders to ensure consistent and pragmatic application of FDA oversight over the total product lifecycle.
  • Interested candidates who are licensed physicians and/or nurses should send their resumes and letters of interest here no later than January 18, 2017.

  • Interested engineering candidates should apply for consideration by clicking on one of the two links below, depending on level of experience, as described in the Qualifications section within USAJobs vacancy announcement no later than January 18, 2017.

  • Questions may be directed to Leondra Ray, Workforce Staffing Specialist, CDRH via email or at (301) 348-1839

Center for Biologics Evaluation and Research (CBER): Jobs and Fellowships

  • CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics. Employment opportunities offer competitive salaries and excellent benefits.

Amarex Clinical Research 

  • Amarex Clinical Research, a global CRO, seeks qualified applicants for multiple positions related to regulatory science and oversight, such as Regulatory and Scientific Analyst, Regulatory Assistant, and Clinical Research Associate. See company website for details.