I can help with question two, but not question three.
The answer to question two is that biotech companies are part of the global industry from day one. Because capital is global, diseases know no borders, people are mobile, and you can get science anywhere in the world, there is an immediate competition with all other bioscience companies in the world.
In other words, when you start a biotech company in the US, you are immediately competing with biotech companies in Japan, the UK, etc. because you're all competing for the same capital, the same consumers, the same pharmacies, etc.
My best guess for question three is just that regulations are always important for global businesses (or really any business in general) as they protect both the businesses, the employees, and the consumers. In the case of biotech businesses, they protect people from false advertising of the benefits of products for example.
Hope this helps!