Interested in a career in regulatory affairs? Click through to find out more!
Written by /u/LifeAfterLifeScience and copied with permission
At the most basic level, you act as a trader in information. You’ll stand at the midpoint between a vast variety of departments, experts and regulators – and you’ll be keeping information flowing between each and every one of them. Emails, reports, meetings, phone calls, the job involves keeping people up to date and in the loop. Communication lies at the heart of regulatory affairs, so expect to do a lot of it.
Are you organised? You’d better be – you’ll be juggling multiple projects at any one time, plus various meetings and whatever emergency has come up this time. Being able to keep track of these requirements is a must. You’ll need to be able to plan both in the short term (today’s chaos) and the long term (what is our 4 year development plan?). This is where the typical scientific background, with its multitasking of experiments, writing, and meetings, really comes in handy.
The job title is Regulatory Affairs Manager, and so it’s fairly clear that there’s management involved. But it’s not ‘management’ in the sense of having people reporting to you and doing the tasks you assign them (well, not until later at least). Instead it’s managing people without actually having any formal authority over them – you can’t give orders, you’ll have to persuade, wheedle, nag, bargain, compromise and trade your way to your goals. This is not to say that people won’t want to help you, but each expert you approach will have a ridiculous number of demands on their time. Why should they help you? You need to be persuasive, and this is why interpersonal skills are one of the main talents HR looks for when hiring.
Writing dossier modules
Want approval to market your miracle drug? First you need to show that you know what you’re doing – that your product is safe, effective, and made in a (consistently) high-quality way. This is done via the dossier, a vast document split into numerous sections covering every stage of the development process and the future plans. As you’d expect, working on a product’s dossier takes up a lot of time. Whether it’s putting together the initial application or making updates to a previously-approved one, a regulatory career will revolve around the dossier.
Working with source documents
This is a pretty big change for people coming in from academia or research: you’re done with laboratory work. Others within the company will be doing protein analysis, clinical studies, purity checks – that’s not your job any more. Instead, you’ll take the work produced by these people (studies and reports), and use that as a basis for their own writing. You still need experience dealing with scientific data and methods (to understand what you are reading!), but the data is produced by others. Your job is to understand these source documents so that you can decide how much of it ends up in the dossier.
Providing regulatory advice
You aren’t just reading reports and writing dossiers. Because companies are always changing their methods (trying to optimise for cost and yield), you’ll be part of the change evaluation process – saying how much regulatory stress is involved in any given change. That clever idea to increase yields by a few percent is less worthwhile when the FDA demands several years of stability data first. Likewise, your advice will be needed to plan these changes. What will be needed to get approval for your drug? What kind of studies will be needed in the final submission? This is where regulatory affairs comes in.
Thoughts on transitioning into reg. affairs straight from the bench?
It depends on the company. Small biotechs will likely be looking for candidates with more experience however large pharma companies often hire people straight out of a PhD or postdoc and train them up.
Kind of interesting?