FDA Regulatory/Healthcare Practice Areas Forum

(On Campus Interviews, Summer Associate positions, Firm Reviews, Tips, ...)
Forum rules
Anonymous Posting

Anonymous posting is only appropriate when you are revealing sensitive employment related information about a firm, job, etc. You may anonymously respond on topic to these threads. Unacceptable uses include: harassing another user, joking around, testing the feature, or other things that are more appropriate in the lounge.

Failure to follow these rules will get you outed, warned, or banned.
Anonymous User
Posts: 428103
Joined: Tue Aug 11, 2009 9:32 am

FDA Regulatory/Healthcare Practice Areas

Post by Anonymous User » Wed Feb 20, 2019 3:15 pm

It looks like we're on the cusp of (or perhaps already in the middle of) massive growth taking place within the biotech/life sciences industry. I'd love to hear about anybody's experience in this practice area (day-to-day work and lifestyle, exit options and relevant comp, etc.).

From looking at other threads I understand that this is a DC-centric practice area, a science background is useful but not absolutely necessary, and exit options generally include reviewing promotional materials for pharmaceutical companies (with comp generally being about 100k-150k for these in-house roles), and obviously government roles with the FDA. It seems like the hours are reasonably high, but because the work is interesting and the exit options are generally good, satisfaction among both associates and partners is high in this area. Probably doesn't hurt that the work involves helping clients advance technology and therapies that could potentially have a meaningful impact on the lives of others, along with being less tied to the deal timeline like transactional folks.

I'd be especially curious whether people with this background are able to parlay their experience into hybrid business/legal roles with biotech companies (corp. dev., marketing, biotech VC would be a stretch but seems like having an FDA background would be useful for a VC fund). Finally, while FDA regulatory work, healthcare (lit, reg, and transactional), and life sciences transactional are all different areas, I'd be curious to know how common it is to see someone with a broad practice scope encompassing one or more of these areas.

Thanks in advance.
Last edited by Anonymous User on Wed Feb 20, 2019 6:30 pm, edited 1 time in total.

Anonymous User
Posts: 428103
Joined: Tue Aug 11, 2009 9:32 am

Re: FDA Regulatory Practice Area

Post by Anonymous User » Wed Feb 20, 2019 3:32 pm

I’m not in the practice area, but my firm does a lot of this work and it is very common for associates to split between FDA regulatory and healthcare regulatory practices. I think splitting with litigation/corporate (even with a specialty) is a lot more rare, even compared to other regulatory areas. (Eg, it isn’t uncommon for someone to split between data privacy regulatory work and litigation, or between FinReg and corporate.) That said, a decent portion of the work at a lot of places would likely include regulatory due diligence/other transactional support.

Anonymous User
Posts: 428103
Joined: Tue Aug 11, 2009 9:32 am

Re: FDA Regulatory Practice Area

Post by Anonymous User » Wed Feb 20, 2019 5:36 pm

I work as an in-house patent attorney for F500 pharma company. I never worked for a firm, but I am involved with a wide range of activities here from normal patent attorney work (opinions, patent prosecution) to Hatch-Waxman work. I also get involved in litigation (usually not directly), drug submissions, portfolio development, business development deals, etc. My background also includes drug development as a scientist in the lab prior to my patent attorney life. Most of the attorneys that my IP group hires come from IP firms. We also have regulatory, litigation, and contract attorneys but their jobs are more focused to a particular area.

What indication do you have that we are on the cusp of massive growth in this field? In my 20 years of working in this field, the industry has consolidated to the point that many of my former colleagues were left scrambling to find work in the United States. Many jobs were pushed off to India/China but most of my former colleagues are scientists.

Anonymous User
Posts: 428103
Joined: Tue Aug 11, 2009 9:32 am

Re: FDA Regulatory Practice Area

Post by Anonymous User » Wed Feb 20, 2019 6:29 pm

Thanks to both posters above. I've just heard generally that the science has advanced such that we should expect to see a lot of growth in the sector in the same way we've seen growth in tech occur over the past few decades. That being said, perhaps I'm misguided and I'd be curious to know whether your view on the instability of jobs in the sector extends to both legal jobs as well as science positions. Certainly seems like the threat of having your job outsourced would be lower in the legal world but maybe I'm wrong.

sandiego222

Bronze
Posts: 103
Joined: Sat Dec 03, 2011 4:21 pm

Re: FDA Regulatory/Healthcare Practice Areas

Post by sandiego222 » Wed Feb 20, 2019 11:13 pm

The regulatory aspect of FDA/healthcare work is centered in DC. But there are large corporate practices focused on biotech/life sciences, in Boston, NY and SV/SF. It seems like that's where a lot of the growth is, especially when you look at the number of biotechs that are hitting the public markets.

Latham, Goodwin and Cooley dominate this work (at least at the IPO/public company level... there may be other players when biotechs are early stage), and Ropes seems to have a lot of underwriter representation as well in this space. Take a look at any of the registration statements for biotechs that have gone public in the last few years, and it will almost always be one of these firms representing the issuer and/or underwriter.

Want to continue reading?

Register now to search topics and post comments!

Absolutely FREE!


Anonymous User
Posts: 428103
Joined: Tue Aug 11, 2009 9:32 am

Re: FDA Regulatory Practice Area

Post by Anonymous User » Thu Feb 21, 2019 9:05 am

Anonymous User wrote:Thanks to both posters above. I've just heard generally that the science has advanced such that we should expect to see a lot of growth in the sector in the same way we've seen growth in tech occur over the past few decades. That being said, perhaps I'm misguided and I'd be curious to know whether your view on the instability of jobs in the sector extends to both legal jobs as well as science positions. Certainly seems like the threat of having your job outsourced would be lower in the legal world but maybe I'm wrong.
I am the poster above - there is probably more growth in the biotech and device areas than small molecules. I am not as familiar with growth in firms dealing with life sciences but there is a decline in general in big pharma jobs as well as the generic industry. I also started at a time where most people worked for the same company for 30-40 years, those times are probably gone for the most part with the ever changing dynamics of this field. Hence, that is probably why my outlook is jaded. Biotech is probably the future with BLA applications and biosimilars but unfortunately I am stuck more on the small molecule side of things with my background. I wouldn't want to discourage you though, there are plenty of jobs - especially if you are not tied to a particular geographic area. I have worked for 4 F500 pharma companies in 4 different states in my career. East Coast, Midwest, and West Coast. I really like my work because I have pretty decent freedom in my daily work plus I am tied into projects from inception through submission and eventual launch.

Another issue right now with pharmaceuticals is the price pressures coming from the government. There is a big push to control drug prices. Any congressional action on drug pricing is likely to have a negative impact on the industry. However, there is a problem with drug prices but I think people are generally wrong in how they want to approach controlling prices.

Anonymous User
Posts: 428103
Joined: Tue Aug 11, 2009 9:32 am

Re: FDA Regulatory/Healthcare Practice Areas

Post by Anonymous User » Mon Feb 25, 2019 9:20 pm

Sorry if I'm hijacking but I will be summering at a firm with a DC office that mainly works FDA regulatory and with other offices (West Coast/Boston/NYC) that do more on the transactional side of Life Sciences (M&A/divestitures/etc). Can anyone speak to the quality of life on each - transactional vs. FDA regulatory? What's the better practice for exit options?

Anonymous User
Posts: 428103
Joined: Tue Aug 11, 2009 9:32 am

Re: FDA Regulatory/Healthcare Practice Areas

Post by Anonymous User » Mon Feb 25, 2019 11:10 pm

As someone working in a V10 M&A-driven specialty practice group, I think that generally speaking the closer you are to the deal the worst QOL you have (this can even extend so called "chill" practice areas like exec comp). I don't know how exactly that works in the FDA/life sciences context, though....perhaps hospitals, research centers, etc. are less demanding clients to deal with?

Anonymous User
Posts: 428103
Joined: Tue Aug 11, 2009 9:32 am

Re: FDA Regulatory/Healthcare Practice Areas

Post by Anonymous User » Tue Feb 26, 2019 10:54 am

Anonymous User wrote:Sorry if I'm hijacking but I will be summering at a firm with a DC office that mainly works FDA regulatory and with other offices (West Coast/Boston/NYC) that do more on the transactional side of Life Sciences (M&A/divestitures/etc). Can anyone speak to the quality of life on each - transactional vs. FDA regulatory? What's the better practice for exit options?
Life Sciences work for a firm that has both regulatory and transactional practices will often involve regulatory support for large deals - e.g., you will have all of the joys of due diligence tight timelines (often due to VC or PE clients) without having to run the deal itself. Whether you prefer the intensity of being a subject matter expert (regulatory) vs the intensity of running the deal (transactional) is probably not something you've thought about at this stage of your career, but will be important for you to focus on experiencing both sides this summer.

Hospitals, research centers, pharma companies, etc. are not necessarily easier to deal with because this is an extremely niche area with highly sophisticated clients working in a heavily regulated space. They know their business; they know their value. That said, and as alluded above, it's more and more common for the health care entity to have little to do with the deal. Instead, it's a private equity firm that is calling the shots.

(Senior associate at one of the type healthcare/life sciences firms)

Want to continue reading?

Register for access!

Did I mention it was FREE ?


Anonymous User
Posts: 428103
Joined: Tue Aug 11, 2009 9:32 am

Re: FDA Regulatory/Healthcare Practice Areas

Post by Anonymous User » Tue Feb 26, 2019 2:36 pm

Anonymous User wrote:
Anonymous User wrote:Sorry if I'm hijacking but I will be summering at a firm with a DC office that mainly works FDA regulatory and with other offices (West Coast/Boston/NYC) that do more on the transactional side of Life Sciences (M&A/divestitures/etc). Can anyone speak to the quality of life on each - transactional vs. FDA regulatory? What's the better practice for exit options?
Life Sciences work for a firm that has both regulatory and transactional practices will often involve regulatory support for large deals - e.g., you will have all of the joys of due diligence tight timelines (often due to VC or PE clients) without having to run the deal itself. Whether you prefer the intensity of being a subject matter expert (regulatory) vs the intensity of running the deal (transactional) is probably not something you've thought about at this stage of your career, but will be important for you to focus on experiencing both sides this summer.

Hospitals, research centers, pharma companies, etc. are not necessarily easier to deal with because this is an extremely niche area with highly sophisticated clients working in a heavily regulated space. They know their business; they know their value. That said, and as alluded above, it's more and more common for the health care entity to have little to do with the deal. Instead, it's a private equity firm that is calling the shots.

(Senior associate at one of the type healthcare/life sciences firms)
Thank you for the response this is the type of information I'm looking for. Is it fair to say that the typical exit from the regulatory practice would be to government (FDA/HHS/Industry or trade groups/etc.) while from the deal side, it would be in-house at a large life sciences company? Or are regulatory attorneys also well positioned to eventually go in-house?

Anonymous User
Posts: 428103
Joined: Tue Aug 11, 2009 9:32 am

Re: FDA Regulatory/Healthcare Practice Areas

Post by Anonymous User » Tue Feb 26, 2019 2:56 pm

Anonymous User wrote:
Thank you for the response this is the type of information I'm looking for. Is it fair to say that the typical exit from the regulatory practice would be to government (FDA/HHS/Industry or trade groups/etc.) while from the deal side, it would be in-house at a large life sciences company? Or are regulatory attorneys also well positioned to eventually go in-house?
No such thing as typical exit strategy except that, given the nichey-ness for healthcare/life sciences, the sweet spot for an in-house or government position that is worth leaving the fantastic world of big-law is more like 6-10 years rather than 3-7 years for traditional corporate work. And given the relative overlap of trans vs. reg, one path does not really close the door on any exit goal.

Anecdotally, there also seems to be a common revolving door with people leaving biglaw to go in-house/gov't and then returning to their feeder firm a few years later as a senior counsel or non-equity partner given the subject matter expertise that they developed in lieu of a book of business. Again, this is a highly regulated area where "dabbling" is extremely dangerous. Practical industry knowledge is invaluable.

Anonymous User
Posts: 428103
Joined: Tue Aug 11, 2009 9:32 am

Re: FDA Regulatory/Healthcare Practice Areas

Post by Anonymous User » Tue Feb 26, 2019 4:10 pm

Separate poster -- thanks for this. Do you generally enjoy the work, or do you view the extended time it takes to go in-house as too restrictive? Ideally I'd enjoy the work enough so that I don't feel like I have to "stick it out" for a decade just to have a decent QOL, so am just trying to gauge whether life at a firm is sustainable long-term in either a transactional or regulatory life sciences role. Thanks.

Anonymous User
Posts: 428103
Joined: Tue Aug 11, 2009 9:32 am

Re: FDA Regulatory/Healthcare Practice Areas

Post by Anonymous User » Tue Feb 26, 2019 4:10 pm

.

Anonymous User
Posts: 428103
Joined: Tue Aug 11, 2009 9:32 am

Re: FDA Regulatory/Healthcare Practice Areas

Post by Anonymous User » Tue Feb 26, 2019 5:21 pm

Anonymous User wrote:Separate poster -- thanks for this. Do you generally enjoy the work, or do you view the extended time it takes to go in-house as too restrictive? Ideally I'd enjoy the work enough so that I don't feel like I have to "stick it out" for a decade just to have a decent QOL, so am just trying to gauge whether life at a firm is sustainable long-term in either a transactional or regulatory life sciences role. Thanks.
It's tolerable suck as a junior because it's new and exciting and you're too green to handle the super complex. It becomes intolerable suck as a mid because you're doing the multi-hour contract review/charting but you also find yourself having to write articles and stay abreast of the industry. And then, if you stick it out long enough, you realize you've developed quite a bit of expertise and it becomes moderately enjoyable suck as a senior (largely because you can relegate the contract charting to juniors) when you're taken seriously, you're engaging your own clients in your specialty area, you're running deals (or portions of them), you're invited to write and speak externally, and you can see a path forward -- whether up or out.

As with anything, enjoying the work is largely dependent on people, but healthcare/life sciences has a pretty low "screamer" population. It can attract a lot of nerdy quasi-introverts who wonk out on policy and regulations and "risk tolerance assessments", even if they operate in a more transactional practice.

Register now!

Resources to assist law school applicants, students & graduates.

It's still FREE!


Post Reply Post Anonymous Reply  

Return to “Legal Employment”