Results for tag: "EU And US Regulatory Affairs"

The European Union (EU) and United States (US) Regulatory Affairs markets in the biotechnology sector are highly competitive and complex. Regulatory Affairs professionals are responsible for ensuring that products comply with applicable laws and regulations, and that they are safe and effective for their intended use. Regulatory Affairs professionals must be knowledgeable about the regulatory environment in which their products are developed and marketed, and must be able to effectively communicate with regulatory authorities. In the EU, the European Medicines Agency (EMA) is responsible for the evaluation and supervision of medicines, while the European Commission is responsible for the regulation of biotechnology products. In the US, the Food and Drug Administration (FDA) is responsible for the regulation of biotechnology products. Companies in the EU and US Regulatory Affairs market in the biotechnology sector include AstraZeneca, Bayer, GlaxoSmithKline, Merck, Novartis, Pfizer, and Roche. Show Less Read more