Readiness for consultancy in Regulatory Affairs

Auxilium

Involved In Discussions
#1
Dear community,
on LinkedIn and also personally, I definitely see consultancies for Regulatory Affairs Consulting. I currently started my Regulatory Career and it is already lasting a couple of months. I work in a high-paced environment and probably learnt much more than in some big corporation with a team of 30 Regulatory People.
I was asking myself: Hm, definitely sounds interesting to be engaged in consulting and the thought seems even more appealing since I am already getting a glimpse of the part of regulatory work that is not fun at all for me: namely processing CAPAs, assessing Incidents in the field and documenting them, problem resolution process for bug fixing and stuff like that to get rid of some burden.
Other than that, I really like understanding those standards and give my own personal interpretation of how to leanly implement that requirement and that I consider a bit superior than other solutions that in my eyes took more time than mine. Does that sound a bit arrogant?
My final question is: How would you decide for yourself if you are ready to give other's advice in a field you have struggled yourself and want to speed up other people's endeavors and charge them money for that? How would you decide that and where do you think is the difficulty of just a one-(wo)man consultancy show? Do you get enough jobs? How do consultancies get jobs anyways?

Thx for reading all this
 
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Ronen E

Problem Solver
Moderator
#2
Dear Auxilium,
Does that sound a bit arrogant?
Yes.
My final question is: How would you decide for yourself if you are ready to give other's advice in a field you have struggled yourself and want to speed up other people's endeavors and charge them money for that?
Giving advice for free is one thing, and charging for it is a very different one. You are most welcome to dispense your advice for free here at Elsmar - I'm sure it will be appreciated. But to charge someone for your advice you will need to either build up a reputation (i.e. that your advice is worth paying for) or otherwise successfully market your goods as unique and valuable ("successfully market" doesn't necessarily mean that the goods are indeed worthy! Sadly, it would just mean you did a good job at marketing).
Do you get enough jobs? How do consultancies get jobs anyways?
That's the hardest part and I think that there is no playbook.

Here's some sobering advice. In essence it's still applicable.

To pass as an RA consultant (actually ANY consultant) you'd normally need more than a few months experience. The same would usually go for an RA Manager position (relating to the other thread you started).

Please don't take it the wrong way - my post is intended more as a wake-up call. Most of all, to succeed in this field you need some humility and a lot of patience (measured in years, if not decades). I believe that there are no real shortcuts, though it might sometimes seem that there are.

All the best,
Ronen
 

Auxilium

Involved In Discussions
#3
Dear Auxilium,

Yes.

Giving advice for free is one thing, and charging for it is a very different one. You are most welcome to dispense your advice for free here at Elsmar - I'm sure it will be appreciated. But to charge someone for your advice you will need to either build up a reputation (i.e. that your advice is worth paying for) or otherwise successfully market your goods as unique and valuable ("successfully market" doesn't necessarily mean that the goods are indeed worthy! Sadly, it would just mean you did a good job at marketing).

That's the hardest part and I think that there is no playbook.

Here's some sobering advice. In essence it's still applicable.

To pass as an RA consultant (actually ANY consultant) you'd normally need more than a few months experience. The same would usually go for an RA Manager position (relating to the other thread you started).

Please don't take it the wrong way - my post is intended more as a wake-up call. Most of all, to succeed in this field you need some humility and a lot of patience (measured in years, if not decades). I believe that there are no real shortcuts, though it might sometimes seem that there are.

All the best,
Ronen
Hey Ronen,
thank you for your humbling answer which I thought about for a while. You definitely provided be some good advice.
I definitely feel like it is hard to work in a RA Manager position just from the start, right? It's not something that people usually do but they tend do rather work in R&D for a few years, get in touch with QA & RA and then end of being in Regulatory Affairs.
Why is it that you specifically say there are no real shortcuts? Do you mean specifically that one needs time to really fulfill this role?
 

Ronen E

Problem Solver
Moderator
#4
I definitely feel like it is hard to work in a RA Manager position just from the start, right?
I think that this is true for most "real" management positions (i.e. where you manage others, not just equipment, processes etc.). You need to be able to guide more junior staff and have their trust. Why would they trust you and accept your guidance? Normally, because you've been in their shoes, gained experience, and proved that you are actually competent in what they're supposed to do. The other case is where someone is super-clever and charismatic - maybe then people will follow them / accept their professional authority anyway; but that's the exception.

It's not something that people usually do but they tend do rather work in R&D for a few years, get in touch with QA & RA and then end of being in Regulatory Affairs.
That's one way to do it. That's how I did it. I never planned to "go into QA/RA", and when I did it there were hardly any RA professionals around (outside regulators). Even certifications like RAPS's were just beginning to emerge, and there wasn't much else going on. RA was usually a function in QA (if at all perceived as a separate function), there were hardly any RA managers, and there was no clear career path in that area.

Today I see a lot of (usually young) people start out in junior RA roles, with minimal or no prior formal training, coming from a variety of fields, then slowly progress through the ranks. Several days ago I received a connection request in LI, from a person who is apparently an experienced QA/RA manager now (worked their way up over some years), and their formal qualification (degree) is apparently in hospitality management!... I guess it can work, but in all honesty I don't like it. Again, there are always exceptions, but in my work I feel that such people are usually applying a mechanistic rule/procedure set, and lack a deep/organic understanding of the rationales/logic behind what we do as people who bring medical devices to clinicians and patients, and are unable to be creative in developing strong and valid regulatory arguments when things get muddy, or make difficult judgement calls (e.g. when you have to confront a NB that is practicing regulatory creep).

Why is it that you specifically say there are no real shortcuts?
Because - as above - getting into this kind of senior roles requires people to have trust in you. It's usually not enough to impress them (even when that impression is mostly justified). Gaining trust takes a long time. You need to be in many different challenging situations and emerge successful in most of them (it's okay to fail sometimes too, because you learn a lot from it). If you don't walk these miles, why would people take your word for something? RA is not an accurate science that you can study in university or from textbooks. It's too vague, to specific, and the exception is the rule... It's a little hard to explain - I think no one actually asked me these questions until now. It seems that a lot of people don't pay attention to these things, and just dive in head first. Some crash and burn, but I guess enough "make it" somehow so that others see and are willing to follow. Maybe I'm wrong and they are right...? I don't know.

What I do know is the difference between good and bad RA work, and very sadly I see tons of the latter and hardly any of the former, which causes huge waste and a lot of unnecessary agony. Apparently a lot of RA staff (junior, misguided by senior staff lacking real professional stature) act as RA junk mills. That RA junk is in turn churned by regulators silly-mills, generating zero added value but apparently keeping everyone politically happy and correct. But hey, maybe from a narrow career perspective that's all right...? Who ever said that all this needs to be high quality and add value?...
 

Auxilium

Involved In Discussions
#5
Dear Ronen,
I am thankful for all your explanations and thoughts. This really helped me. We will hear each other in the future as well
 
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