Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,

I have recently taken on a role as RA Manager with 2 RA team members. However, our registration pipeline is significant for the next 3 years. I'm looking to develop a business case for additional headcount which can support with day to day registration activities but also help other RA team members while I'm away or occupied with other high-level projects.

Please share some examples or templates on how to manage this successfully. I have reached out to our internal HR head and according to them a business case is required and there is no current template for support functions such as RA.

Thank you.

Hi Anonymous.

I usually hate building these cases because in many organizations the RA function is considered a "money pit" because they don't "make products", "sell products" or "manufacture products" and therefore the work they do only "costs" money.  While I know we can all make a great case for how compliance, on-time submissions, first submission approval rates and all the other great metrics we can measure actually "make" the company money by being able to move forward better or having the widest indications, etc. the business folks typically don't like to consider those positives unless they are well-versed in the importance of regulation management.

With that said, I have had some success when approaching this using the idea that personnel involved in the submissions can improve the overall functioning of the business with the following potentially measurable outcomes:

1. Submissions being sent in on time (or early) for the product allow for improved potential for approval of the product on time and hitting the market launch dates in the different countries;
2. Where product markets are being expanded, it is a potential for moving forward to make the market launch on time again;
3. For every week that you are late to getting the submission into the regulator it is costing you ~2% of your planned turnover for the first year - this cost is "real" whether the business folks consider it correct or not.
4. When looking at the workload, determine what is the general level of effort to pull together the documentation that you need to submit, organize the data, submit the data, then answer the question of how much work might be involved in responding to questions or getting the answers for the questions.  Again, if this is >80 hrs/wk for the 2 people on the team, you have a basis for the business case in general.
5. Assess what having your team able to back each other up as well as potentially backing you up while on other issues/business for the company provides to the company.  Again, people will be out of the office at some point for at least 6 weeks per year on vacation (assuming that all 3 of you get 2 weeks vacation per year - a somewhat unlikely situation in the current work setting).  This obviously doesn't account for the time that people will be out of the office either in meetings, trainings, or even just ill.  If you can't back up the group it ends up costing days that will hurt your timeline in the future when you are trying to get the product approved.
6. The key metric is often not just what is coming up in the next few years but more about the idea of what is the day-to-day work that you need to cover with the additional headcount.  You really need to have a look at what the work is and how many hours will need to be allotted for the work to be done.  This includes all of the routine work, all of the regular updates (think any sort of notifications or analysis required by country regulators, how to manage submissions of information even after the approvals, etc.) that will be required and then include things like training, meeting attendance, future work as noted previously, etc. 

This becomes a major key point because if you can't support the need for a FTE (full time employee) longer term you will have a hard time with your business case.  It might bode well for you to look into the potential of bringing on contract employees if you need specific help at specific times rather than bringing in FTEs unless you can ensure that your workload is going to be supportive of the extra FTE hours.  If you aren't sure, maybe a temp or a temp-to-perm type setup might be more palatable to your organization.  I don't like the temp or temp-to-perm options because these employees require essentially the same level of training and work as an FTE without the benefit of the person being an FTE and the business being able to eliminate the position extremely rapidly.  On the plus side, if the person isn't working out these can be good "proving" ground strategies but the costs can still be considerable especially if you really need the person and just can't show the hiring committee that you need them.

------------------------------
Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States
------------------------------

Original Message:
Sent: 04-Apr-2022 19:17
From: Anonymous Member
Subject: Seeking business case advise for additional RA headcount in the team

This message was posted by a user wishing to remain anonymous

Hi,

I have recently taken on a role as RA Manager with 2 RA team members. However, our registration pipeline is significant for the next 3 years. I'm looking to develop a business case for additional headcount which can support with day to day registration activities but also help other RA team members while I'm away or occupied with other high-level projects.

Please share some examples or templates on how to manage this successfully. I have reached out to our internal HR head and according to them a business case is required and there is no current template for support functions such as RA.

Thank you.

Hello, Anonymous,
From my experience you need to collect some evidence of the work that was done and how much money it brought. It is also important from this point of view to align with Marketing on priorities while showing how much time is required to compile each submission. Those explanations are always somewhat uneasy, but eventually people start seeing the point.
I personally found it difficult to support the need to cover some "routine work that RA do besides submissions: working with marketing's requests, providing some legislative support, writing regular reports, supporting Customs and Logistics departments.  It all needs time, but business doesn't really see it as "real work".
So at one of my previous companies Global RA made a requirement to submit, e.g., tender's cost in case Marketing needs some additional information from RA (technical characteristics, descriptions etc.). So, e.g., when we sent a request from regional offices to International RA we had to state that this information is required for "5000K tender. At the end of a year they collected all this information and they could show to the business how much money they actually helped to earn.
My point is that we really have to be creative sometimes to make other departments see what we do how much we work.

Good luck)

------------------------------
Oksana Kolosova
Moscow
------------------------------

Original Message:
Sent: 04-Apr-2022 19:17
From: Anonymous Member
Subject: Seeking business case advise for additional RA headcount in the team

This message was posted by a user wishing to remain anonymous

Hi,

I have recently taken on a role as RA Manager with 2 RA team members. However, our registration pipeline is significant for the next 3 years. I'm looking to develop a business case for additional headcount which can support with day to day registration activities but also help other RA team members while I'm away or occupied with other high-level projects.

Please share some examples or templates on how to manage this successfully. I have reached out to our internal HR head and according to them a business case is required and there is no current template for support functions such as RA.

Thank you.

Dear All,  

The business case needs to take into account the corporate goals that have been communicated to investors or to the market that are "material" in nature and affect the ability to raise capital or impact stock value.  The business case is focused on the business as it is impacted by key regulatory goals and objectives.  I tend to focus head count needs on what won't happen if there is not enough staff or support to ensure RA will be able to for example, submit a planned FIH IND on time, which will impact study start, which will impact a press release on study start.  The business case should also focus on risk and probability along with the goal and objective.  What is the risk to the organization if an annual report is not submitted on time, etc.  Whether day-to-day or project based, head count requirements should align with current maintenance activities, planned goals and objectives as they require RA support and proposed future opportunities.  I would create a MS plan for all activities, allocate resources and cost, and then prioritize what must be done with what will be needed. Identify the risk and potential of that risk and then create a business case and timing for additional head count aligned with the plan.  


There are many ways to present the case, key is to focus on key activities that will get the attention of the CFO or Chief of Staff that manage head count allocation.  

Good luck,

Dar

------------------------------
Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States
------------------------------

Original Message:
Sent: 08-Apr-2022 17:52
From: Oksana Kolosova
Subject: Seeking business case advise for additional RA headcount in the team

Hello, Anonymous,
From my experience you need to collect some evidence of the work that was done and how much money it brought. It is also important from this point of view to align with Marketing on priorities while showing how much time is required to compile each submission. Those explanations are always somewhat uneasy, but eventually people start seeing the point.
I personally found it difficult to support the need to cover some "routine work that RA do besides submissions: working with marketing's requests, providing some legislative support, writing regular reports, supporting Customs and Logistics departments.  It all needs time, but business doesn't really see it as "real work".
So at one of my previous companies Global RA made a requirement to submit, e.g., tender's cost in case Marketing needs some additional information from RA (technical characteristics, descriptions etc.). So, e.g., when we sent a request from regional offices to International RA we had to state that this information is required for "5000K tender. At the end of a year they collected all this information and they could show to the business how much money they actually helped to earn.
My point is that we really have to be creative sometimes to make other departments see what we do how much we work.

Good luck)

------------------------------
Oksana Kolosova
Moscow

Original Message:
Sent: 04-Apr-2022 19:17
From: Anonymous Member
Subject: Seeking business case advise for additional RA headcount in the team

This message was posted by a user wishing to remain anonymous

Hi,

I have recently taken on a role as RA Manager with 2 RA team members. However, our registration pipeline is significant for the next 3 years. I'm looking to develop a business case for additional headcount which can support with day to day registration activities but also help other RA team members while I'm away or occupied with other high-level projects.

Please share some examples or templates on how to manage this successfully. I have reached out to our internal HR head and according to them a business case is required and there is no current template for support functions such as RA.

Thank you.

Hi Anon,

You have gotten some good advice here already, but I will add my $0.02....

First, as everyone said, try and quantify how much time any given submission (up front and responses) takes, as well as the "required" routine work (which will vary from company to company but may include annual reports, document reviews, ad/promo, audit support, diligence support etc). Then lay out the "pipeline" over the next few years and show how many man hours are needed, and thus, what could be dropped or slowed down if you don't get this headcount.

Then emphasize all the steps you have already taken (or will be taking) to reduce these hours. This can be automating things, specializing in geographies, outsourcing certain things, training your team - whatever. You want management to think you only requested headcount after trying everything else - not first!

Finally, it looks like you specifically want a higher level role to better help the team. Your business case should specifically indicate how this will help the company - for instance, specific expertise in important geographies, or experience negotiating with FDA supporting a key milestone, of ability to help support QA too (or whatever).

Good luck!

Ginger

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 08-Apr-2022 18:17
From: Darlene Rosario
Subject: Seeking business case advise for additional RA headcount in the team

Dear All,

The business case needs to take into account the corporate goals that have been communicated to investors or to the market that are "material" in nature and affect the ability to raise capital or impact stock value.  The business case is focused on the business as it is impacted by key regulatory goals and objectives.  I tend to focus head count needs on what won't happen if there is not enough staff or support to ensure RA will be able to for example, submit a planned FIH IND on time, which will impact study start, which will impact a press release on study start.  The business case should also focus on risk and probability along with the goal and objective.  What is the risk to the organization if an annual report is not submitted on time, etc.  Whether day-to-day or project based, head count requirements should align with current maintenance activities, planned goals and objectives as they require RA support and proposed future opportunities.  I would create a MS plan for all activities, allocate resources and cost, and then prioritize what must be done with what will be needed. Identify the risk and potential of that risk and then create a business case and timing for additional head count aligned with the plan.


There are many ways to present the case, key is to focus on key activities that will get the attention of the CFO or Chief of Staff that manage head count allocation.

Good luck,

Dar

------------------------------
Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States

Original Message:
Sent: 08-Apr-2022 17:52
From: Oksana Kolosova
Subject: Seeking business case advise for additional RA headcount in the team

Hello, Anonymous,
From my experience you need to collect some evidence of the work that was done and how much money it brought. It is also important from this point of view to align with Marketing on priorities while showing how much time is required to compile each submission. Those explanations are always somewhat uneasy, but eventually people start seeing the point.
I personally found it difficult to support the need to cover some "routine work that RA do besides submissions: working with marketing's requests, providing some legislative support, writing regular reports, supporting Customs and Logistics departments.  It all needs time, but business doesn't really see it as "real work".
So at one of my previous companies Global RA made a requirement to submit, e.g., tender's cost in case Marketing needs some additional information from RA (technical characteristics, descriptions etc.). So, e.g., when we sent a request from regional offices to International RA we had to state that this information is required for "5000K tender. At the end of a year they collected all this information and they could show to the business how much money they actually helped to earn.
My point is that we really have to be creative sometimes to make other departments see what we do how much we work.

Good luck)

------------------------------
Oksana Kolosova
Moscow

Original Message:
Sent: 04-Apr-2022 19:17
From: Anonymous Member
Subject: Seeking business case advise for additional RA headcount in the team

This message was posted by a user wishing to remain anonymous

Hi,

I have recently taken on a role as RA Manager with 2 RA team members. However, our registration pipeline is significant for the next 3 years. I'm looking to develop a business case for additional headcount which can support with day to day registration activities but also help other RA team members while I'm away or occupied with other high-level projects.

Please share some examples or templates on how to manage this successfully. I have reached out to our internal HR head and according to them a business case is required and there is no current template for support functions such as RA.

Thank you.

Hello -
In addition to providing a generalized percentage of time to compile and submit AND support that submission with additional MOH requests, I would also pull together the potential ROI for each market you are looking to expand to. Leadership who are not versed in RA like numbers and how much the business stands to make in the investment you are after. If you break down your submission cadence quarterly, the amount of time each one will take depending on the dossier requirements and show how much that market is expected to generate over a three year projection, it may be easier to visualize your strategy. I would focus on Globalizing the company and where you see the company expanding in the next five years. 

Hope this helps!

------------------------------
Kathleen Gallagher Santos
Regulatory Affairs Specialist
Jacksonville FL
United States
------------------------------

Original Message:
Sent: 04-Apr-2022 19:17
From: Anonymous Member
Subject: Seeking business case advise for additional RA headcount in the team

This message was posted by a user wishing to remain anonymous

Hi,

I have recently taken on a role as RA Manager with 2 RA team members. However, our registration pipeline is significant for the next 3 years. I'm looking to develop a business case for additional headcount which can support with day to day registration activities but also help other RA team members while I'm away or occupied with other high-level projects.

Please share some examples or templates on how to manage this successfully. I have reached out to our internal HR head and according to them a business case is required and there is no current template for support functions such as RA.

Thank you.