Regulatory affairs professionals

[Robert]

Although this may not be considered a truly pharmaceutical topic, there some of us who choose to spend their hours working in the RA department. If you're lucky, you may work at some headquarters, if not, you're probably in some affiliate office. And then still you might get lucky, and get to work in an so-called MRP/DCP center, as I have the good fortune to do.

Question: am I the only one on thos forum here who works in this department? Would it be worthwile to maybe exchange some questions, discuss e.g the new variation regulation? Perhaps your gripe with MHRA, or EMA? I notice that even on the TOPRA forum there is hardly any activity going on, so I thought maybe this forum would have a few people that might be interested.

So, if you're in RA, or have a question about it, let's hear it!

Robert

[DavidS]

Hi Robert,
Johnep is interested in this, and I know Johannes works in this kind of are in Germany. So, you are not alone.

[johnep]

Well I would not say very interested, but it fell to me to write all the applications for Product Licences of Right in the late 60s.
I was worried about meeting the deadline, but we were Nbr 61 so lots after us. I used to write Specs as well, as got fed up asking the lab. I still write my own Certs Analysis for my small export business. I wanted the documents to look good as part of marketing. Here is an example.
Formatting lost and could not upload to photobucket as word file not pic.

Certificate of Conformity.
Batch Dated : "Best Before March 2012" has been tested and found to conform with the specification below. If stored in closed container, then shelf life is unlimited.

Date of Test: March 2007.
Magnesium Carbonate Light
Hydrated Basic Magnesium Carbonate
3MgCO3. Mg(OH)2. 3H2O

Properties-
Description: White Microcrystalline Powder

Specification

Assay MgO 40-45%
Apparent specific gravity 120 – 175

Maximum Levels of Impurities

Insolubles in acetic acid 0.05% max
Soluble substances 1.00% max
Chloride as Cl 0.07% max
Arsenic as As 2ppm max
Calcium as Ca 0.75% max
Iron as Fe 400ppm max
Heavy metals 20ppm max
Identification Positive
Appearance of solution Passing Test
Sulphate as SO4 0.30% Max

Meets the requirements of Ph.Eur 1997

Packaging: 20kg Bags.



johnep

[Hector]

Hi, is it possible to move from Regulatory Affairs to Quality Assurance/QP roles? I think I remember reading a profile of someone who made such a move. Anyone heard of people going in this direction? I currently work an affiliate Regulatory Office.

Hector.

[Robert]

Hi, is it possible to move from Regulatory Affairs to Quality Assurance/QP roles? I think I remember reading a profile of someone who made such a move. Anyone heard of people going in this direction? I currently work an affiliate Regulatory Office.

Hector.

Sure, provided you are qualified. Are you a pharmacist? In that case such a move can usually be made. Make sure to look up local regulations on additional requirements. In the Netherlands, just being a pharmacist (or pharmaceutical scientist, chemist or even a veterinarian or medical doctor) is not enough. There are additional requirements, especially with regard to having worked in industry, under the supervision of a more senior QP. I've seen people moving in either direction, and I have also worked in both fields.

[Hector]

Thanks for your reponse Robert. Yes, I am a Pharmacist. In Ireland I think the law is the same as in the Netherlands. Appropriate degree & experience is required in order to register. I was thinking about undertaking the MSc that fulfills the educational requirments of the QP also. That said I am unsure if it would be a waste of time, as there is no substitute for hands on experience in QA. Being based in an office, I may be better off to move to a plant first & then do the MSc.

[Robert]

You know, doing a MSc is in itself a great time investment, even if you never use the content of it again. In NL a MSc is requirement, by the way (if I am not mistaken, of course).

[Hector]

Anybody ever get Regulatory Affairs Certified (RAC) through RAPS or the Certificate? Looks like quite a good programme & pretty cost-effective. TOPPRA seems to be on the pricey side!

Hector

[paranoid android]

Hi yeah I’m in the RA area. I can see Robert’s point about the luck of the draw. I have been working for an affiliate and it would appear to be a more difficult environment than a central department.
I have recently resigned from my position as I am looking for a more pure RA position in more autonomous RA operations where I could be taken under the wing of RA managers rather than being rather isolated in a small affiliate. I can do community pharmacy locums in the meantime otherwise I wouldn’t have resigned without finding something new. Wish me luck. Yes the RAC programme looks good for strengthening your CV unfortunately I have only 1.5 years experience in RA so am only halfway towards being eligible for it
Robert, I could discuss with you forever new variations procedures . I don’t know where to start! Did you attend the MHRA seminar in January? It was very worthwhile anyway I found

[sfp20]

Hi there, I am extremely interested in RA

I am a MPharm graduate and doing my pre-reg at community (rejected by the industrial schemes..) I am very passionate about being as a RA and I think this position gives you loads of opportunities to your career development within a pharma company (am i right?). I am a TOPRA member and had researched quite alot about the RA (HR websites, TOPRA rapporteur / RA career intro booklet, sanofi youtube channel etc...). I think I have only obtained the very 'surface' info about RA and I want to ask you some questions about the 'real' RA.

1. What is the starting salary of a RA? (in terms of a MPharm graduate, speaks Mandarin, Cantonese and English). What I see in the career sites is something around 20k pound annually, which is far less than being a community nor hospital pharmacist...(26k - 36k)

2. What exactly does a RA do? (intro vids and articles mentioned RA is like a project manager / communicator / hub between departments) in the reality, do we spend over 80% of the time working on documents eg. the CTD, MA, submissions, regulatory updates? On the other hand, as I know in a big company, the RA department is divided into different divisions, eg. generic / diabetic / packaging etc... Say if I work in the packaging division, do I ALWAYS deal with the PILs / packaging only?

3. Title and the development of a RA, adverts of RA in career sites tend to show "powerful" title, such as RA Executive / senior manager of RA /Head of RA needed (with requirement of 3-5+ yrs only) What's the next step you can get to after being such a high level with only that much of experience?

4. What's the benefit to work in the headquarter instead of affiliate office? Do you prefer to work in a CRO / consultancy OR big pharma?

Thanks very much .....more questions to come..