FDA Regulatory practice groups? Forum

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Smalltowngal

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FDA Regulatory practice groups?

Post by Smalltowngal » Tue Jul 05, 2022 5:12 pm

I saw a few other postings about this but specifically wanted to ask how is the WLB in FDA regulatory practice groups, which mostly seem to be in DC?

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Re: FDA Regulatory practice groups?

Post by s7e35k914 » Tue Jul 05, 2022 5:55 pm

Smalltowngal wrote:
Tue Jul 05, 2022 5:12 pm
I saw a few other postings about this but specifically wanted to ask how is the WLB in FDA regulatory practice groups, which mostly seem to be in DC?
my understanding is that WLB is great in FDA regulatory, with respect to big law standards of course. but I would love to hear more chime in.

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Re: FDA Regulatory practice groups?

Post by Anonymous User » Sat Jul 09, 2022 6:17 pm

I'm in an FDA regulatory group in DC and I have friends in the same practice group at another firm. It's hard to compare it to other groups without experiencing those groups firsthand. We do some work supporting corporate groups and generally the lawyers on the corporate side are more demanding and have expectations that we don't have in our group. We are definitely very busy and have to work on weekends or pull late nights sometimes, but it's not the default expectation. Holiday and vacation time is respected unless there really IS a fire drill.

But, big law is still big law, no matter what. There is no such thing as WLB. A family member was asking about my social life and I honestly said that I don't have one. I personally don't have the energy for it even when we have slower weeks. I have to use that time to physically and mentally recover from the intense weeks and to take care of real-life things that usually fall by the wayside. I also need a lot of sleep to feel refreshed and productive. I think big law is a better fit for some people than others. I'm not sure that it's wise to try to suss out the "better" practice groups for WLB. It's more a matter of what you can handle and make work.

Also wanted to add that everyone in my group is great to work with and for. So, my experience of lack of WLB is not due to dealing with screaming partners or anything. I can't even imagine putting up with big law if I had to deal with screaming partners or cutthroat associates.

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Re: FDA Regulatory practice groups?

Post by Anonymous User » Sun Jul 10, 2022 11:20 pm

Anonymous User wrote:
Sat Jul 09, 2022 6:17 pm
I'm in an FDA regulatory group in DC and I have friends in the same practice group at another firm. It's hard to compare it to other groups without experiencing those groups firsthand. We do some work supporting corporate groups and generally the lawyers on the corporate side are more demanding and have expectations that we don't have in our group. We are definitely very busy and have to work on weekends or pull late nights sometimes, but it's not the default expectation. Holiday and vacation time is respected unless there really IS a fire drill.

But, big law is still big law, no matter what. There is no such thing as WLB. A family member was asking about my social life and I honestly said that I don't have one. I personally don't have the energy for it even when we have slower weeks. I have to use that time to physically and mentally recover from the intense weeks and to take care of real-life things that usually fall by the wayside. I also need a lot of sleep to feel refreshed and productive. I think big law is a better fit for some people than others. I'm not sure that it's wise to try to suss out the "better" practice groups for WLB. It's more a matter of what you can handle and make work.

Also wanted to add that everyone in my group is great to work with and for. So, my experience of lack of WLB is not due to dealing with screaming partners or anything. I can't even imagine putting up with big law if I had to deal with screaming partners or cutthroat associates.
How do you like being an FDA Regulatory lawyer?

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Re: FDA Regulatory practice groups?

Post by Anonymous User » Mon Jul 11, 2022 2:24 am

Anonymous User wrote:
Sat Jul 09, 2022 6:17 pm
I'm in an FDA regulatory group in DC and I have friends in the same practice group at another firm. It's hard to compare it to other groups without experiencing those groups firsthand. We do some work supporting corporate groups and generally the lawyers on the corporate side are more demanding and have expectations that we don't have in our group. We are definitely very busy and have to work on weekends or pull late nights sometimes, but it's not the default expectation. Holiday and vacation time is respected unless there really IS a fire drill.

But, big law is still big law, no matter what. There is no such thing as WLB. A family member was asking about my social life and I honestly said that I don't have one. I personally don't have the energy for it even when we have slower weeks. I have to use that time to physically and mentally recover from the intense weeks and to take care of real-life things that usually fall by the wayside. I also need a lot of sleep to feel refreshed and productive. I think big law is a better fit for some people than others. I'm not sure that it's wise to try to suss out the "better" practice groups for WLB. It's more a matter of what you can handle and make work.

Also wanted to add that everyone in my group is great to work with and for. So, my experience of lack of WLB is not due to dealing with screaming partners or anything. I can't even imagine putting up with big law if I had to deal with screaming partners or cutthroat associates.
Also a DC firm FDA regulatory lawyer. Agree with all of this, and wanted to add that, unlike how I understand lit and corporate groups to be, we don't really have a lot of "easy" billable hours, like doc review or basic diligence. Lots of headache-inducing complicated legal questions, and fewer hours you can simply churn away at. I think that makes FDA regulatory work challenging from a WLB perspective even if we aren't necessarily billing crazy hours. I imagine this is also the case for other regulatory practice groups, but don't know that firsthand.

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Re: FDA Regulatory practice groups?

Post by Anonymous User » Mon Jul 11, 2022 1:22 pm

Can you meet your billables? Do you find making partners in this area more difficult?

Smalltowngal

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Re: FDA Regulatory practice groups?

Post by Smalltowngal » Mon Jul 11, 2022 6:43 pm

I appreciate the honest answers so far!

In your experience, how the exit ops for your practice group? Anecdotally, I have heard that pharma and biotech companies have a great need for such attorneys. After how many years of practice do you think it is possible to go in-house with a nice or at least somewhat decent (i.e., $150K or above) salary?

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Re: FDA Regulatory practice groups?

Post by Anonymous User » Tue Jul 12, 2022 12:56 am

Smalltowngal wrote:
Mon Jul 11, 2022 6:43 pm
I appreciate the honest answers so far!

In your experience, how the exit ops for your practice group? Anecdotally, I have heard that pharma and biotech companies have a great need for such attorneys. After how many years of practice do you think it is possible to go in-house with a nice or at least somewhat decent (i.e., $150K or above) salary?
What firms are the biggest players in this space?

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

Re: FDA Regulatory practice groups?

Post by Anonymous User » Thu Jul 14, 2022 1:54 pm

Anonymous User wrote:
Mon Jul 11, 2022 2:24 am
Anonymous User wrote:
Sat Jul 09, 2022 6:17 pm
I'm in an FDA regulatory group in DC and I have friends in the same practice group at another firm. It's hard to compare it to other groups without experiencing those groups firsthand. We do some work supporting corporate groups and generally the lawyers on the corporate side are more demanding and have expectations that we don't have in our group. We are definitely very busy and have to work on weekends or pull late nights sometimes, but it's not the default expectation. Holiday and vacation time is respected unless there really IS a fire drill.

But, big law is still big law, no matter what. There is no such thing as WLB. A family member was asking about my social life and I honestly said that I don't have one. I personally don't have the energy for it even when we have slower weeks. I have to use that time to physically and mentally recover from the intense weeks and to take care of real-life things that usually fall by the wayside. I also need a lot of sleep to feel refreshed and productive. I think big law is a better fit for some people than others. I'm not sure that it's wise to try to suss out the "better" practice groups for WLB. It's more a matter of what you can handle and make work.

Also wanted to add that everyone in my group is great to work with and for. So, my experience of lack of WLB is not due to dealing with screaming partners or anything. I can't even imagine putting up with big law if I had to deal with screaming partners or cutthroat associates.
Also a DC firm FDA regulatory lawyer. Agree with all of this, and wanted to add that, unlike how I understand lit and corporate groups to be, we don't really have a lot of "easy" billable hours, like doc review or basic diligence. Lots of headache-inducing complicated legal questions, and fewer hours you can simply churn away at. I think that makes FDA regulatory work challenging from a WLB perspective even if we aren't necessarily billing crazy hours. I imagine this is also the case for other regulatory practice groups, but don't know that firsthand.
so do you think this practice is not much better on the WLB front than any either biglaw practice?

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Anonymous User
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Re: FDA Regulatory practice groups?

Post by Anonymous User » Thu Jul 14, 2022 3:28 pm

Anonymous User wrote:
Tue Jul 12, 2022 12:56 am
Smalltowngal wrote:
Mon Jul 11, 2022 6:43 pm
I appreciate the honest answers so far!

In your experience, how the exit ops for your practice group? Anecdotally, I have heard that pharma and biotech companies have a great need for such attorneys. After how many years of practice do you think it is possible to go in-house with a nice or at least somewhat decent (i.e., $150K or above) salary?
What firms are the biggest players in this space?
Covington and Hogan, in that order. Sidley is very good at pharmaceutical regulatory work but doesn't really do any food/cosmetics regulatory work. There are also some boutiques (Keller & Heckman, Hyman Phelps & McNamara, etc.) that are very good at FDA regulatory work, but I don't know if they hire people out of law school.

Anonymous User
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Re: FDA Regulatory practice groups?

Post by Anonymous User » Fri Jul 15, 2022 12:05 am

Anonymous User wrote:
Thu Jul 14, 2022 3:28 pm
Anonymous User wrote:
Tue Jul 12, 2022 12:56 am
Smalltowngal wrote:
Mon Jul 11, 2022 6:43 pm
I appreciate the honest answers so far!

In your experience, how the exit ops for your practice group? Anecdotally, I have heard that pharma and biotech companies have a great need for such attorneys. After how many years of practice do you think it is possible to go in-house with a nice or at least somewhat decent (i.e., $150K or above) salary?
What firms are the biggest players in this space?
Covington and Hogan, in that order. Sidley is very good at pharmaceutical regulatory work but doesn't really do any food/cosmetics regulatory work. There are also some boutiques (Keller & Heckman, Hyman Phelps & McNamara, etc.) that are very good at FDA regulatory work, but I don't know if they hire people out of law school.
What about Latham and Ropes?

Anonymous User
Posts: 408502
Joined: Tue Aug 11, 2009 9:32 am

Re: FDA Regulatory practice groups?

Post by Anonymous User » Fri Jul 15, 2022 3:00 am

Anonymous User wrote:
Mon Jul 11, 2022 2:24 am
Anonymous User wrote:
Sat Jul 09, 2022 6:17 pm
I'm in an FDA regulatory group in DC and I have friends in the same practice group at another firm. It's hard to compare it to other groups without experiencing those groups firsthand. We do some work supporting corporate groups and generally the lawyers on the corporate side are more demanding and have expectations that we don't have in our group. We are definitely very busy and have to work on weekends or pull late nights sometimes, but it's not the default expectation. Holiday and vacation time is respected unless there really IS a fire drill.

But, big law is still big law, no matter what. There is no such thing as WLB. A family member was asking about my social life and I honestly said that I don't have one. I personally don't have the energy for it even when we have slower weeks. I have to use that time to physically and mentally recover from the intense weeks and to take care of real-life things that usually fall by the wayside. I also need a lot of sleep to feel refreshed and productive. I think big law is a better fit for some people than others. I'm not sure that it's wise to try to suss out the "better" practice groups for WLB. It's more a matter of what you can handle and make work.

Also wanted to add that everyone in my group is great to work with and for. So, my experience of lack of WLB is not due to dealing with screaming partners or anything. I can't even imagine putting up with big law if I had to deal with screaming partners or cutthroat associates.
Also a DC firm FDA regulatory lawyer. Agree with all of this, and wanted to add that, unlike how I understand lit and corporate groups to be, we don't really have a lot of "easy" billable hours, like doc review or basic diligence. Lots of headache-inducing complicated legal questions, and fewer hours you can simply churn away at. I think that makes FDA regulatory work challenging from a WLB perspective even if we aren't necessarily billing crazy hours. I imagine this is also the case for other regulatory practice groups, but don't know that firsthand.
Counterpoint that at least at my firm a lot of the FDA work is deal support, so as a junior you end up doing a lot of diligence, which is an easy way to bill hours (though there's steep learning curve). I'm a junior but it seems like if your group is small even the seniors end up doing a fair amount of this too.

Anonymous User
Posts: 408502
Joined: Tue Aug 11, 2009 9:32 am

Re: FDA Regulatory practice groups?

Post by Anonymous User » Fri Jul 15, 2022 8:15 pm

Anonymous User wrote:
Fri Jul 15, 2022 3:00 am
Anonymous User wrote:
Mon Jul 11, 2022 2:24 am
Anonymous User wrote:
Sat Jul 09, 2022 6:17 pm
I'm in an FDA regulatory group in DC and I have friends in the same practice group at another firm. It's hard to compare it to other groups without experiencing those groups firsthand. We do some work supporting corporate groups and generally the lawyers on the corporate side are more demanding and have expectations that we don't have in our group. We are definitely very busy and have to work on weekends or pull late nights sometimes, but it's not the default expectation. Holiday and vacation time is respected unless there really IS a fire drill.

But, big law is still big law, no matter what. There is no such thing as WLB. A family member was asking about my social life and I honestly said that I don't have one. I personally don't have the energy for it even when we have slower weeks. I have to use that time to physically and mentally recover from the intense weeks and to take care of real-life things that usually fall by the wayside. I also need a lot of sleep to feel refreshed and productive. I think big law is a better fit for some people than others. I'm not sure that it's wise to try to suss out the "better" practice groups for WLB. It's more a matter of what you can handle and make work.

Also wanted to add that everyone in my group is great to work with and for. So, my experience of lack of WLB is not due to dealing with screaming partners or anything. I can't even imagine putting up with big law if I had to deal with screaming partners or cutthroat associates.
Also a DC firm FDA regulatory lawyer. Agree with all of this, and wanted to add that, unlike how I understand lit and corporate groups to be, we don't really have a lot of "easy" billable hours, like doc review or basic diligence. Lots of headache-inducing complicated legal questions, and fewer hours you can simply churn away at. I think that makes FDA regulatory work challenging from a WLB perspective even if we aren't necessarily billing crazy hours. I imagine this is also the case for other regulatory practice groups, but don't know that firsthand.
Counterpoint that at least at my firm a lot of the FDA work is deal support, so as a junior you end up doing a lot of diligence, which is an easy way to bill hours (though there's steep learning curve). I'm a junior but it seems like if your group is small even the seniors end up doing a fair amount of this too.
why steep learning curve? is there any way to prepare for it?

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Anonymous User
Posts: 408502
Joined: Tue Aug 11, 2009 9:32 am

Re: FDA Regulatory practice groups?

Post by Anonymous User » Sun Jul 17, 2022 10:05 pm

Smalltowngal wrote:
Mon Jul 11, 2022 6:43 pm
I appreciate the honest answers so far!

In your experience, how the exit ops for your practice group? Anecdotally, I have heard that pharma and biotech companies have a great need for such attorneys. After how many years of practice do you think it is possible to go in-house with a nice or at least somewhat decent (i.e., $150K or above) salary?
have heard that there's an abundance of in-house options for FDA regulatory lawyers. most companies probably prefer 3-5 years minimum of experience.

Smalltowngal

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Posts: 7
Joined: Tue Mar 20, 2018 1:13 pm

Re: FDA Regulatory practice groups?

Post by Smalltowngal » Mon Aug 01, 2022 11:46 pm

Anonymous User wrote:
Sun Jul 17, 2022 10:05 pm
Smalltowngal wrote:
Mon Jul 11, 2022 6:43 pm
I appreciate the honest answers so far!

In your experience, how the exit ops for your practice group? Anecdotally, I have heard that pharma and biotech companies have a great need for such attorneys. After how many years of practice do you think it is possible to go in-house with a nice or at least somewhat decent (i.e., $150K or above) salary?
have heard that there's an abundance of in-house options for FDA regulatory lawyers. most companies probably prefer 3-5 years minimum of experience.
I wonder where most of these are centered? DC? New York? What about big states like Texas and California?

Anonymous User
Posts: 408502
Joined: Tue Aug 11, 2009 9:32 am

Re: FDA Regulatory practice groups?

Post by Anonymous User » Tue Aug 02, 2022 11:45 am

Smalltowngal wrote:
Mon Aug 01, 2022 11:46 pm
Anonymous User wrote:
Sun Jul 17, 2022 10:05 pm
Smalltowngal wrote:
Mon Jul 11, 2022 6:43 pm
I appreciate the honest answers so far!

In your experience, how the exit ops for your practice group? Anecdotally, I have heard that pharma and biotech companies have a great need for such attorneys. After how many years of practice do you think it is possible to go in-house with a nice or at least somewhat decent (i.e., $150K or above) salary?
have heard that there's an abundance of in-house options for FDA regulatory lawyers. most companies probably prefer 3-5 years minimum of experience.
I wonder where most of these are centered? DC? New York? What about big states like Texas and California?
New poster to the thread.

My first in-house FDA regulatory law role was in a non-DC/non-NYC company. Consider looking in pockets of areas where there are healthcare/med device/biotech companies (such as San Diego, Bay Area, Research Triangle, Seattle, etc).

Anonymous User
Posts: 408502
Joined: Tue Aug 11, 2009 9:32 am

Re: FDA Regulatory practice groups?

Post by Anonymous User » Tue Aug 02, 2022 5:43 pm

Anonymous User wrote:
Tue Aug 02, 2022 11:45 am
Smalltowngal wrote:
Mon Aug 01, 2022 11:46 pm
Anonymous User wrote:
Sun Jul 17, 2022 10:05 pm
Smalltowngal wrote:
Mon Jul 11, 2022 6:43 pm
I appreciate the honest answers so far!

In your experience, how the exit ops for your practice group? Anecdotally, I have heard that pharma and biotech companies have a great need for such attorneys. After how many years of practice do you think it is possible to go in-house with a nice or at least somewhat decent (i.e., $150K or above) salary?
have heard that there's an abundance of in-house options for FDA regulatory lawyers. most companies probably prefer 3-5 years minimum of experience.
I wonder where most of these are centered? DC? New York? What about big states like Texas and California?
New poster to the thread.

My first in-house FDA regulatory law role was in a non-DC/non-NYC company. Consider looking in pockets of areas where there are healthcare/med device/biotech companies (such as San Diego, Bay Area, Research Triangle, Seattle, etc).
Adding in Boston & Minnesota here, both of which have big medical device markets.

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Anonymous User
Posts: 408502
Joined: Tue Aug 11, 2009 9:32 am

Re: FDA Regulatory practice groups?

Post by Anonymous User » Tue Aug 02, 2022 6:12 pm

In your experience, how the exit ops for your practice group? Anecdotally, I have heard that pharma and biotech companies have a great need for such attorneys. After how many years of practice do you think it is possible to go in-house with a nice or at least somewhat decent (i.e., $150K or above) salary?

While you typically need at least three years experience to to get a greater variety and amount of exit opportunities, it's definitely possible to make a move sooner. I've been talking to recruiters about companies open to associates with just one year of experience. The pay range is $150k to $180k all-in. Obviously, pre-law school relevant experience or other qualifications (e.g. a Ph.D.) helps.
Can you meet your billables? Do you find making partners in this area more difficult?

It's generally possible to meet billables. Certainly less precarious if the firm's billable requirement is around 1900 or 1950. It's probably a little easier to make partner. Experience at the FDA helps (and is encouraged by firms).

Smalltowngal

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Posts: 7
Joined: Tue Mar 20, 2018 1:13 pm

Re: FDA Regulatory practice groups?

Post by Smalltowngal » Thu Aug 04, 2022 7:25 pm

Anonymous User wrote:
Tue Aug 02, 2022 6:12 pm
In your experience, how the exit ops for your practice group? Anecdotally, I have heard that pharma and biotech companies have a great need for such attorneys. After how many years of practice do you think it is possible to go in-house with a nice or at least somewhat decent (i.e., $150K or above) salary?

While you typically need at least three years experience to to get a greater variety and amount of exit opportunities, it's definitely possible to make a move sooner. I've been talking to recruiters about companies open to associates with just one year of experience. The pay range is $150k to $180k all-in. Obviously, pre-law school relevant experience or other qualifications (e.g. a Ph.D.) helps.
Can you meet your billables? Do you find making partners in this area more difficult?

It's generally possible to meet billables. Certainly less precarious if the firm's billable requirement is around 1900 or 1950. It's probably a little easier to make partner. Experience at the FDA helps (and is encouraged by firms).
This is great to know. In terms of in-house positions, what are the titles typically? Haven't seen any "FDA counsel" titles, so I'm guessing maybe something like "corporate counsel"?

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

Re: FDA Regulatory practice groups?

Post by Anonymous User » Thu Aug 04, 2022 10:27 pm

This is great to know. In terms of in-house positions, what are the titles typically? Haven't seen any "FDA counsel" titles, so I'm guessing maybe something like "corporate counsel"?

Various titles with "counsel" in them - just plain counsel, associate counsel, associate general counsel, assistant general counsel, senior counsel and so on. The job description is what will mention FDA.

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

Re: FDA Regulatory practice groups?

Post by Anonymous User » Fri Aug 05, 2022 12:28 am

Anonymous User wrote:
Tue Aug 02, 2022 6:12 pm
In your experience, how the exit ops for your practice group? Anecdotally, I have heard that pharma and biotech companies have a great need for such attorneys. After how many years of practice do you think it is possible to go in-house with a nice or at least somewhat decent (i.e., $150K or above) salary?

While you typically need at least three years experience to to get a greater variety and amount of exit opportunities, it's definitely possible to make a move sooner. I've been talking to recruiters about companies open to associates with just one year of experience. The pay range is $150k to $180k all-in. Obviously, pre-law school relevant experience or other qualifications (e.g. a Ph.D.) helps.
Can you meet your billables? Do you find making partners in this area more difficult?

It's generally possible to meet billables. Certainly less precarious if the firm's billable requirement is around 1900 or 1950. It's probably a little easier to make partner. Experience at the FDA helps (and is encouraged by firms).
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