Regulatory affairs is a relatively new and demanding career. It requires extensive knowledge of the business, legal, and pharmaceutical aspects of products in development, so that projects can be operated smoothly from inception to market.
A regulatory affairs specialist is responsible for keeping up-to-date with all of the rules and regulations that govern the production process for new drugs, cosmetics, and other medical products. And while it is an incredibly rewarding career both emotionally and financially, there are some specific skills that can help you succeed in this profession.
If you’re interested in a career that encompasses the specifics of multiple (very different) fields, this may be the right choice for you. If so, read on to find out which skills can help you make it as a regulatory affairs specialist.
1. A Career in Regulatory Affairs Requires an Eye for Detail
For students who are considering regulatory affairs as a potential career path, one of the most important skills to have is an eye for detail. One of the most important elements of a regulatory affairs specialist’s job is to parse through and review thousands of pages of documents. This is to ensure that all proper legal, business, and pharmaceutical protocols are being followed. Specialists sometimes need to write their own complex, detailed documents as well.
Reviewing and being able to understand all the details in these documents, whether you are reading or writing them, is a skill that is invaluable for a regulatory affairs specialist. An eye for detail as well as the proper training can help you excel in this role.
2. Students of Regulatory Affairs Courses Know the Fundamentals of Business, Law, and Science
Another skill that is necessary for being a successful regulatory affairs specialist is not innate, but rather honed through a comprehensive regulatory affairs program. The skill in question is the possession of a strong understanding of multiple different fields, ranging from business to law to science. Given that the position is involved in every step of the production process, from the initial idea through to its final iteration as it hits the market, being able to understand and juggle multiple fields at once is crucial. If it came to light that the product did not follow the right protocol in whatever way, it could potentially be recalled—a very costly mistake for companies to deal with.
3. Having a Passion for Helping People is Vital for Regulatory Affairs Specialists
At its core, students who take regulatory affairs courses want to help people in need, and they believe that working in this capacity will help make the lives of those who suffer better or easier. They aren’t wrong.
Generally, companies that employ regulatory affairs specialists have their treatments pass through the approval process quicker than their counterparts, which is why the field has exploded since its debut around 30 years ago. Pharmaceutical companies have been jumping to hire these regulatory affairs specialists, in order to make sure that everything runs smoothly. A smooth, efficient operation can get a product to market faster—a product which will improve the lives of those in need.
Are you interested in regulatory affairs programs?
Visit the Academy of Applied Pharmaceutical Sciences (AAPS) for more information or to speak with an advisor!