ABSTRACT
The global regulations have been fast-evolving. More and more countries have seen the need for mandatory regulations for therapeutic products and are set to implement these, if they haven’t yet. Regulators understand that the industry will always ask for information. The better understanding of the industry has on the regulations, the better the quality of the dossiers that they submit, the faster the regulators can do their evaluations. Regulatory affairs provide a very good opportunity to work our creative juices and think out of the box. Regulatory affairs management is hard work. The sort of relationship works in the business setting, for both internally and working with our authorities.
