Friday, March 23, 2012

What is it like to be... a regulatory type?

A reader writes in to ask about careers on the regulatory side of the house. I'll be really honest and say that I don't really know what it's like, other than the fact you're no longer standing 3+ hours a day in the lab. (That's bad, right? Right??!?)

Here's Lisa Balbes' blurb (from her book "Nontraditional Careers in Chemistry") of what the regulatory folks do:
Because of stringent regulations, companies that makes pharmaceutical products, medical devices and related products are those most likely to employ people to monitor regulations in specific areas, prepare submissions to regulatory agencies, and guide a product or product line through premarket approval, manufacturing, labeling and on through to advertising and post-release surveillance. These regulatory affairs professionals are involved in the entire product cycle, from development to widespread commercial use. 
Readers, any thoughts?  


  1. Whilst I haven’t personally made the final leap to Reg A (or QA depending on internal terminology), I have spent much of my recent life collaborating very closely with them (ex-synthetic, now Pharm Dev / QC). The world of Quality is a very interesting and challenging career path for those in the crowd who are detail oriented, and have a natural inclination towards regulation and adherence. The rigours of science still exist here, and individuals who have a high degree of underlying understanding of their discipline can do well, especially in the initial phases of their QA career. Coming from the lab you’d likely be placed as a reviewer of GMP (and to a lesser degree GLP) processes and data; process chemists, with their understanding of residual solvents / metals, impurity profiles and reproducibility would be better suited than med chemists (the wild west of GxP).

    Quality units are in place to help design the best systems and processes beforehand, and to ensure that what was ordered to happen, happened. They’re also an invaluable resource when stuff (inevitably) goes screwy, in determining root causes and potential outcomes, developing remedies, and documenting everything along the way so as to present the regulatory agencies with a scientifically sound, compliant, and risk-minimized report of your work.

    I’ve heard QA units being defamed for seemingly ignoring science in the name of compliance, and that internal auditors are all hard-asses out to get the poor folks in the lab, but after suffering through 6 weeks of FDA audits, I can tell you that they’re nowhere near as rough as the feds, and if the QA team gives you grief about something, then the agency will too, and theirs comes with 483’s.

    In terms of career prospects, I think it has greater expansion potential in the coming years than jobs in discovery. Quality work is tough to outsource, is required throughout the entire lifecycle of a product, and the government isn’t reducing its oversight anytime soon.

  2. All respect due to Dr. Balbes, but I found her book, Nontraditional Careers in Chemistry, to be rather unhelpful. It was good to get a good 5000 mile view of a career, but I would have preferred a more in-depth discussion of day-to-day life within those careers. Your excerpt is a great example. It really doesn't tell me what the career would be like nor does it tell me if I would even enjoy doing it. Additionally, and this is more of a comment on the types of careers chosen for discussion, most of the careers Dr. Balbes discusses require additional schooling. I don't know about the post-doc next to me, but after 4 yrs undergrad, 6 yrs grad, I'm about fed up with more schooling, nor do I want the added debt. Business side? Gotta get the MBA. Patent law? Gotta go to Law school. Regulatory affairs? Well, you gotta get RAPS certified. After 10 yrs of schooling, you'd think that'd be enough, right? Right?

    1. So I should really note here that the blurb was one small paragraph of a 24 page chapter with 4 (at least) profiles of regulatory professionals. See for yourself:

      When I get a second, I'll try to directly answer your questions from the book.

  3. Regulatory professional here. There are a few benefits and a few drawbacks to this type of role.

    For many, many people, these positions are a gateway type of position. These positions allow individuals to get into an organization, and from there they may transfer to another role that they feel more passionate about. My department has seen this happen with 3 out of the past 4 new hires.

    Further, while many of these positions are desk jobs, it is possible to find a position that has a laboratory function as well, if that's your fancy. The big, beautiful world of complaint investigations and CAPA is one of these. For events that are potentially reportable, investigations need to occur. Depending on what the alleged product deficiency is, you could just do a quick d dig for documents, or you could end up spending an inordinate amount of time in the lab.

    This brings me to my next point - You will never be bored. In order to function in this role, you have to know a lot about a lot of things. You need to know the regulations, their requirements, and how practices meet these requirements. You need to know everything about the product. You need to have a solid knowledge in the science of the product, because if you are responsible for investigating an alleged deficiency, you will need every scientific tool in your tool belt.

    Because you have such a wide knowledge base, you are likely to stay despite layoffs. For reportable events, all reports to the FDA must occur within a given timetable (either 5 calendar days after first notification to any company employee, or 30, depending on the product and claim). The FDA has a "tough love" policy for the companies, so much as to have stated that understaffing is not a valid reason for a late submission. While layoffs do happen, and have happened, I'd say there's a certain amount of job security on that side of the house.

    For what I've seen, the pay is a little bit better on the regulatory side. Granted I've only completed this role at two of the largest Pharmaceutical companies, but in comparison, there's a bit higher pay.

    Will you cure cancer in this role? No. There is little glory in saying, "I'm a regulatory professional." It's not sexy. But can your work potentially save lives? Sure. If your identify a product deficency, your work can help people.

    If you have your PhD, will you put it to good use? Probably not in the same extent as the R&D folks, but perhaps, depending on your role. I, for instance, only have my bachelors. I typically do more paper-pushy type of roles, however my position also has a tiny amount of lab grunt work as well. My boss has a Masters. One of the people on the same level as me has a PhD. We're a hodgepodge. I guess what I'm saying is that depending on your role, you might not need more schooling, as someone else pointed out. Will it help? Sure, I suppose it looks nice on a resume. Is it really, really necessary? Not really. Most of the companies train you on their requirements, as well as many of the FDA regulations.

    1. Anon 233p, thanks for your time and expertise -- it's helpful.

    2. Wow- that's really insightful. I've considered Regulatory affairs in the past, but was told those guys are mostly jerks. (You know, in contract to the angels who decide to run their own lab.) Do you spend most of your time reading and writing? Work as a team, or are you the sole expert on your technology? Thanks for that start- maybe I'll have to go track down my own Regulatory Pro to ask more questions of.

  4. Over the past several years, as the job prospects for PhDs has dwindled to nothing, RA was touted as a great place for them to go as an alternative to bench work. However, I don't understand how a fresh graduate could possibly jump into this role. You have absolutely no experience doing anything that RA requires, aside from being able to read and write. But will you be able to do any of the things CanChem or Anon233 described? You don't know the first thing about the regulatory environment in a company coming out of school/postdoc. This is one of those positions where I think you actually do need to have industrial experience to be able to do it well, as opposed to bench positions, where I think years of experience are used as a pre-selection filter for applicants.

    1. Two points on my experience with Reg A jobs - I have seen more people transition to Reg A / QA from other departments than direct from school, but not every person in was experienced in the industry.

      I don't know whether the general career path of School -> Research -> Regulatory is because most schools don't teach these skills or talk about the jobs, so people don't think about it as a career path. Whether companies expect recent grads to have these skills is an interesting question, as people coming out of school and into GMP-regulated labs generally don't know the first thing about the regulatory environment either. Companies (at least the three I've been with) are prepared to educate their new employees, and fortunately there are two factors working in the new hire's favour: 1) Every company follows the regulation in their own particular way, and to ensure consistency and compliance, they'll need to train you in their systems, processes and procedures, and 2) EVERYTHING (and I mean everything) about how to do your job in a regulated area must be written down. This helps newbies out because they're coming in to a world where everything they need to know to start doing their job is required reading for the first two weeks on a site.

      The challenge in all this is proving to someone that you're worthy of training; if you've done it before you're in better shape than if you haven't, but again, I've seen many (probably ~20% of all new people) hires join without any previous experience. However, as is always the case, the more credentials you have, the more specific the hiring role will likely be; if you have your PhD companies generally expect a greater level of knowledge and leadership to go along with the expected higher starting salary. I'm very happy right now to have left after defending my MSc, as I've been able to have greater lattitude in my career than if I had my PhD. This isn't to say that you won't get offered a position if you've got your PhD, but don't expect them to offer you vastly more than a comparable MSc or BSc to start if you're going for something way outside your field. Where the PhD pays off is after a couple of years (conditional on good work), where PhD's get placed into positions of authority and higher pay brackets (not always the case, and whether this is because they have the PhD, or because they have the work ethic and innate intelligence necessary to complete a PhD).

      Ok, so I've been rambling for a while (not enough coffee), but in summation, you can get a job in QA/RA straight out of uni. It's harder to get a job with a PhD than it is with an MSc or BSc (not unique to RA/QA). If you're interested in the field (or QC work, which can sometimes be a bit more accessible and transitions well to QA), consider a smaller company where diverse skills come in handy (fewer people = everyone does more parts of the operation). Also, not every person in Quality that I've worked with (or most as far as I can recall) has specific certification and training in it (especially at smaller shops). I know there are a few schools around me (Boston) that offer a program in Reg A, but at many companies I haven't seen this required.

  5. One does not simply get a job in regulatory affairs.