With so many differences in research and regulation, it’s more important now than ever for job seekers considering moving outside of the U.S. to educate themselves before they make the leap.
As the life science industry continues to grow across the world, there are certain sects of the industry that differ greatly based on location, specifically in research and regulatory bodies.
While it is possible to find life science jobs in nearly any country, the vast majority of positions are located in a handful of nations. Pharmaceutical companies, for example, are most often headquartered in countries like the United States, Switzerland and Japan, but have branch offices and conduct research and development activities in many other nations. The same is true for medical device manufacturers, biotechnology firms and other companies involved in the life sciences.
In 2021, Proclinical evaluated multiple countries to determine the leading countries for life science job seekers. The United States, France and Germany topped the list with the United States leading the pack with nearly 1.2 million jobs in the life sciences.
With so many different regulatory structures, reimbursement systems and cultural attitudes toward healthcare, it’s more important now than ever for job seekers considering moving outside of the U.S. to educate themselves before they make the leap.
Clinical Research
Clinical research is heavily regulated in all developed countries, and the specific regulations vary from nation to nation. In general, though, clinical research must be conducted according to Good Clinical Practices (GCPs), which are a set of international ethical and scientific quality standards.
One major difference between the United States and other countries when it comes to clinical research is the way in which clinical trials are conducted. In the United States, most clinical trials are conducted by for-profit contract research organizations (CROs). These CROs are paid by life sciences companies to conduct trials on their behalf. In other countries, such as the United Kingdom and Australia, many clinical trials are paid for by academic medical centers and hospitals.
The United States also has more stringent regulations governing clinical research than most other countries. For example, the FDA requires that all clinical trials be registered in a public database, and they must be conducted according to a detailed protocol approved by the FDA. In addition, the FDA imposes strict requirements on the informed consent process, which must be followed in all clinical trials conducted in the United States.
Regulatory Affairs
The regulatory affairs function is responsible for ensuring that life sciences products comply with the regulations of the countries in which they will be marketed. Regulatory affairs professionals work with government regulators to get new products approved and to update existing products on the market.
They also work with other members of the life sciences team, such as clinical researchers and product managers, to ensure that products are developed and marketed in compliance with the law. Regulatory affairs jobs are found in all countries with life sciences industries, but the vast majority are located in developed countries with strong regulatory regimes.
For example, in Germany, a regulatory affairs professional should be knowledgeable about the country’s intricate system of health insurance and reimbursement. Particularly, Germany’s system is decentralized, with each of the 16 states having its own regulations. In the United States, on the other hand, a regulatory affairs specialist may need to be familiar with the FDA’s approval process for new drugs and devices.
These differences could come into play when a life sciences company is looking to expand its operations into new markets. A company that wants to sell its products in the United States will need to comply with FDA regulations, which may be different from the regulations in other countries. Similarly, a company that wants to sell its products in Germany will need to comply with the country’s decentralized system of health insurance and reimbursement.
This regulatory compliance is a key part of the life sciences industry, and it’s an area where there is always a need for qualified professionals.
Bottom Line
In general, while most life sciences careers are similar regardless of where they are located, there are some important differences that life science professionals should be aware of when working in different countries.
This is especially significant in regulations and research, which can vary significantly from one country to the next.
When looking for life science jobs, it’s important to keep these international differences in mind. As the life sciences industry continues to globalize, an understanding of the various systems and regulations in different countries will become increasingly important for those working in the field.