You might think the Reg Affairs department is full of a bunch of rule followers. And you'd be right. But they're also the people that can strategically navigate the many regulations, guidance documents, and country-specific nuances to ultimately achieve the goal of bringing the drug to the patient. Think of your favorite spy movie where someone has to shimmy through a bunch of lasers to get to the treasure in the middle of the room. The treasure is that sweet sweet approval letter. Because at the end of the day, you need the drug to be approved in order to give it to patients, right?
Reg touches just about every other department (aka they have all the tea). There's several teams within Reg Affairs, including:
Strategy: The ones with the big master game plan. They're submitting applications in multiple countries. They're meeting with Health Authorities like the FDA. They're coordinating the many moving parts of getting a product from early development to approval and beyond.
Ad/Promo: The ones who tell Commercial what to do. jk. But they do help prevent the company getting slapped with an FDA Warning Letter, usually sitting in on meetings with other departments as an advisor of sorts to make sure all rules and regs are followed in promotional materials.
Labeling: You've read enough package inserts in school to last a lifetime. If you want to graduate to writing them, Labeling is the place to be. The label means a lot to a lot of people - Market Access for formulary placement, Commercial for what they'll be allowed to say, etc. This team has to balance the interests of all these stakeholders while handling lengthy negotiations with regulatory authorities about the final draft.
**Fellowships may focus on one or all of these areas, so make sure you're asking each position what is included in the program. You can also ask if it’s US focused or will have ex-US exposure.**
Now, you might be wondering some SKILLS important for a successful regulatory professional. Glad you asked...
Detail oriented: The obvious one. Honestly, this is a given for most pharmacy students, but it is nevertheless important.
Diplomatic: You might have to tell your colleagues that they need to scrap a brochure they worked very hard on because it doesn't follow the rules. If you're diplomatic, you can reach a solution together and maintain a good relationship. When you're further on in your career, this skill will come into play at regulatory authority meetings
Solution-oriented: It's easy to look at the regulations and guidances and think about all the things you CAN'T do, but a successful regulatory professional will read between the lines and see the possible strategies moving forward. Hone this skill.
Context: What precedents are out there? What have other companies tried and failed? What are the regional happenings/cultural values that will play into a regulator's opinion on your submission? These are the questions you need to be able to ask.
Like the title says, this is just a snippet. Keep networking and asking questions to learn more, and in the mean time, keep up with those FDA press releases.