Careers: Global Regulatory Affairs in Drug Development

December 01, 2020
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Money Icon Career Outlook

The Global Regulatory Affairs in Drug Development certificate offers individuals already working in the industry with an opportunity to acquire advanced training in clinical research activity as conducted and required by the US Food and Drug Administration (US FDA) and by other regulatory agencies.

Career opportunities in this drug development are substantial. According to EvaluatePharma’s World Preview 2019, Outlook to 2024, prescription drug sales are expected to reach $1.18 trillion by 2024. The report notes that immuno-oncology line extensions significantly contribute to growth as well as the emergence of novel technologies such as cell and gene therapy mark an inflection point in pharma’s evolution.

The Bureau of Labor Statistics expects faster than average growth in clinical research

In the US, the Bureau of Labor Statistics (BLS) predicts that regulatory affairs managers, along with other managers, will grow by 6-8% from 2018 to 2028. Further, regulatory affairs managers will continue to be needed as they contribute to the development of treatments and medicines that improve human health.

What You Can do with a Global Regulatory Affairs in Drug Development Certificate

Graduates of the program will be well suited to serve any of the following organizations:

  • Regulatory agencies including institutional review boards and companies involved in conducting site visits, audits, and compliance investigations
  • Companies developing pharmaceutical/biopharmaceutical and devices
  • Contract research organizations (CROs) that participate in conducting clinical trials
  • Contract laboratories involved in pre-clinical formulations and development of drug delivery systems
  • Companies involved in bioanalytical, pathology, 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-blind trials
  • Academic Health Centers and Research Institutions and community-based research groups

Depending on academic and professional background, the acquired knowledge and skills will equip students to start or advance their careers.

Those with BS degrees may find an entry-level position such as the indicated 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.

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
  • Consultants specializing in the development and testing of generics, biogenerics, sustained-release formulations, and fixed-dose combinations.

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