Global Regulatory Affairs in Drug Development

GC

Why study Global Regulatory Affairs in Drug Development?

The development of new drugs, including biological therapeutic agents and devices is a multifaceted, complex and expensive process. It is estimated that the development of a new drug after initial stages of discovery, can take up to 15 years and cost up to $2 billion dollars. The Pharmaceutical industry in under unpresented pressure to reduce the time to market and to reduce the cost of research and development. 

The Global Regulatory Affairs in Drug Development certificate program is designed to provide biomedical students and professionals an opportunity to learn about the global regulatory framework within which all scientific activities and business strategies are pursued.

Admission Requirements

Students who have earned at least an undergraduate degree in chemistry, biology, engineering, or related disciplines from an accredited institution are eligible to apply for admission to the certificate program. Similarly, applicants with a completed professional degree such as a PharmD, MD, or DVM meet eligibility requirements. 

>>Apply to the Global Regulatory Affairs in Drug Development Certificate Program

Programmatic minimum admission criteria include:

  • A U.S. bachelors degree from a regionally accredited college or university, or an equivalent degree from a non-U.S. university
  • A grade-point average (GPA) of at least 3.00 or equivalent
  • If English is not your native language, a Test of English as a Foreign Language (TOEFL) of at least 90 (internet-based) or 235 (computer-based) is required. Alternatively, an IELTS- minimum score of 6.5 overall band, or Duolingo English test of at least 110 is accepted. 

The graduates of this certificate program are likely to find suitable jobs in the following:

  • Companies developing pharmaceutical/biopharmaceutical and devices.

  • Contract research organizations that participate in pre-clinical (ADMET) and clinical trials.

  • Contract laboratories involved in pre-clinical formulations and development of drug delivery systems.

  • Companies involved in bioanalytical and testing of drug products.

  • Contract manufacturing facilities such as those involved in pharmaceutical product manufacturing as well as specialized packaging for example the special needs for double trials. 

  • Academic Health Centers and Research Institutions and community-based research groups.

Depending on the student's academic and professional background, the acquired knowledge and skills will equip student to start or advance their career: 

  • Those with BS degree may find an entry level position such in the above-indicate companies, either as research assistants and/or quality assurance/regulatory guides. Those with relatively advanced degrees (MBAs) will have opportunities to serve as Project Managers.

  • Those with specific scientific skills (Pharm D, MS, Ph.D., Post-Docs) may serve as scientific leads or project leaders depending on their areas of expertise and experience. Specialized opportunities - in the current economic climate our recent experience suggests that some of the basic scientists working in the academic settings (primarily as post-docs) seek such opportunities to transition to an industry career, where they may be involved as: 

    • Therapeutic experts

    • Medical writers

    • Medical Liaison 

  • Serve as consultants specializing in the development and testing of generics, biogenerics, sustained release formulations and fixed dose combinations. 

The information provided is sourced from a third party, Lightcast. Their product, called Career Coach, combines extensive labor market data from Lightcast and the U.S.Bureau of Labor Statistics. It provides insights on industry, occupation, compensation, and projected growth for each profession. Economic and workforce information is available for various geographic regions. Some careers may require additional training or education.

The Certificate program faculty and program advisors will communicate all course descriptions and requirements to the students about the Global Regulatoray Affairs in Drug Development Certificate program.

UC James L. Winkle College of Pharmacy faculty have a strong track record of research and mentoring in drug development research (molecular pharmacology, biomarkers, pharmacokinetics, drug safety (including mechanistic bases for drug-drug interactions/adverse drug reactions), and formulation of novel drugs.

Students must complete (4) courses and 12 credit hours in order to graduate with a certificate in Global Regulatory Affairs in Drug Development.

Students are eligible to transfer to the program from other colleges or universities. Transfer credits will based on course equivalency and are viewed on a  case-by-case basis after reviewing the approved transcript.

If English is not your native language, a Test of English as a Foreign Language (TOEFL) of at least 90 (internet-based) or 235 (computer-based) is required. Alternatively, an IELTS- minimum score of 6.5 overall band, or Duolingo English test of at least 110 is accepted. 

Explore unique opportunities, faculty, and resources available in Pharmaceutical Sciences

Application Deadlines

Spring semester: December 1

Summer semester: April 30

Fall semester: August 1

The University of Cincinnati and all regional campuses are accredited by the Higher Learning Commission.

Contact Information

Pankaj Desai
231 Albert Sabin Way
3005 Medical Sciences Building
Cincinnati, OH 45267
(513) 558-3870
pankaj.desai@uc.edu

Find related programs in the following interest areas:

Program Code: 25GC-GRDD-GC-.GRDD-DL