This article is aimed at listing down the simple steps/facts, which I hope will help in solving the big riddle of getting a job in the field of regulatory affairs !
First of all, I would
like to share my personal experiences in pursuit of job in the field
of Regulatory Affairs. After my B.Pharmacy, I was pretty much sure that I
wanted to get into RA., so I enrolled into the course offered by BII-Industry Program
in RA, which was famous back then. I also enrolled into a short term industry
oriented course for pharma graduates which included RA as one of the topics. I
had also began researching regarding RA on the internet, but could get info in
bits and pieces (This was the reason for me to start Regulatory One).
After considerable time
of enrolling into the above courses, I got a call for interview in my first
company. I had few more freshers (beginners) for competition at the time of
interview. I cleared the interview and got the job due to the fact that I had
done suitable home work and my research study on DMF (Drug Master files), which
was part of my course, was of great help. I am trying to state the fact that,
if you want to get a job, you need to have special skills which are not there
with your competitors!
The information which I
learnt, while I worked on Regulatory One, helped me to get my 2nd job.
Gaining Skills in Regulatory Affairs -
- If you have done M.pharmacy (not in RA)- My suggestion would be-do a diploma/PG diploma course related to RA through part-time/distance. My personally preferred course and institute is PG Diploma in Pharmaceutical Regulatory Affairs from Jamia Hamdard University since it is accredited by NAAC in 'A' category and they have contact classes in major cities. The feed back I received regarding the course was that, its good.
- If you are B. Pharmacy graduate and want to make a career in RA -I would recommend you to do M.Pharmacy in Pharmaceutical RA .
The list of institutes offering M.Pharmacy in RA are given in the below link.
- Browse, through the websites of Regulatory Agencies like FDA, MHRA, CDSCO and try to gain as much knowledge as possible. In the below page of Regulatory One, Link to the updated news section in the websites of premier regulatory agencies of world is provided.
- In FDA's website there are
links like CDER learn , Educational Resources and Webinars which
contain lots of useful information. Similarly there are training modules
in MHRA' s website.Of course, all the above listed useful links are
absolutely free to access !
- Among all the ICH guidelines- M4 (and allied guidelines M4Q, M4S, M4S), Q1A , Q1E ,Q2, Q3A, Q3B, Q3C, Q6A are the most important references for RA professionals. Knowing them is very important.
- Go through all the articles,
which I have written in Regulatory One. I personally believe that, if a
beginner goes to the interview after reading the articles that I have
written, they could easily clear the interview.
- The below listed link is very useful at the time of interview, especially for beginners (freshers).
Writing Skills -
- For a Regulatory Affairs professional, having good writing skills is very important, since he/she is involved in compilation of dossiers, responding to queries from regulatory agencies.
- Make sure that, you have a well formatted, unique resume which is different from others. If possible, get the resume reviewed by an expert. Ensure to highlight the course which you have done related to RA and specific skill with respect to RA.
- Upload your resume in job websites like Monster and Naukri. Ensure to fill up all your details and have a complete profile.
- Have your detailed profile,
with special emphasis on your educational qualification, skills related to
regulatory affairs.
- Ensure that the information is
given in a properly structured manner, without any grammatical errors.
- Ensure that the photo which you
have uploaded is a one in which you are in formal dress and definitely not
the one, which you had taken during your vacation in a casual dress!
- Join groups related to
Regulatory Affairs like Drug Regulatory Affairs, Global Regulatory
Affairs, Regulatory Affairs Job Opportunities etc and take
active part in discussions in a relevant way.
- Request people who are in
senior positions in RA field to be part of your Networks. If they accept
to be part of your network, send them an email,(in a
properly structured manner, without any
typo/grammatical errors) requesting them to let you know if there are
any openings in their company. Respect their privacy, and do not ask them
for their personal numbers. If they see your profile and
they find you to be good enough, they may definitely let you
know, if there are any openings.
General Misconceptions- I
guess, some of you might have got the free advice- "Start of your career
by working in Quality Control /Quality Assurance. Then you will have a better
chance of getting a job in RA". This logic is absolute false. Why will a
company prefer a person with experience in QC/QA over a person with experience
in RA ?
Guys,
a person who is a fresher (beginner) can get a job in RA. The best example is,
myself !
Hope,
the above article will help you in getting a job in the field of
Regulatory Affairs.
Best
of Luck!
P.S-
- The above article is intended, mainly for the people from India, who are interested to make a career in
the field of RA.
- I am not in a
position where I could refer/recommend for a job. So, kindly do not email
me your resumes.
This is good article for freshers,please give your advises in future also.
ReplyDeleteThanks, Pradeep!
DeleteThanks a lot Rajesh for sharing such a useful information.......All the articles in Regulatory one are really quite very beneficial.......
ReplyDeletehi Rajesh,
ReplyDeleteThank you so much for posting nice articles on RA stuff. I am looking for similar course for my sister, but she did MSc (organic chemistry)..is there any univ in USA that take Chem grads for this course.
thanks for reply
srinivas banala
Hi Srinivas,
DeleteFor Admission into Masters in Regulatory Affairs, most of universities have requirement of Bachelor degree/bachelor degree in related field, which I think are met by your sister.
For official confirmation, contact the concerned person from respective university.
You could refer the links of Universities from the following post, most of which give details of Admission requirements.
http://www.regulatoryone.com/2011/10/universities-offering-masters-courses.html
Regards,
Rajesh
Hi rajesh,
ReplyDeleteFirst of all Greetings!
Myself Manikanta.K .I like your blog very much and i am a follower as well.these days it seems you are not quite in updating your blog.Anyway, this is the first time and with full conscious i am replying to your article.
I would not agree with a part of this article especially regarding Misconceptions-" why ll a company prefer a person from other department than from RA". Here you could mislead some of our pharma guys who are working in other fields and aspiring to come to RA and you are making them not to think about RA rather than encouraging them to try for it. I ll agree with you that most of the companies do not prefer guys from other fields but not all.
Indeed, i myself stand for a best Example.
Best regards,
Manikanta.K
Hi Manikanta,
DeleteYou have misunderstood, what I meant to say. I never stated that, people from other departments cannot get into RA.
I wanted to state the fact that, people can join RA department as a fresher.
Hope,you got the point, what I meant to say.
Regards,
Rajesh Y
Hi rajesh,
DeleteI have correctly understood what you said and i wanted reply to the particular statement you made (Why will a company prefer a person with experience in QC/QA over a person with experience in RA) that a person with experience in other departments also can make a shift to RA if he got really interested and also well prepared for that.This is where i made myself an example.
Infact, it's a bit difficult but not impossible.
Best regards,
Manikanta.K
Thank you very much. This really helped me with my work. I appreciate your help. Thanks a lot. good website
ReplyDeleteNail Gel
Hi,
ReplyDeleteFirst, thanks a lot Rajesh for sharing such a useful information.
My self Pradeep, having a question. Presently working in R&D (about 6 yrs, with API & discovery back ground) and now planning to move to RA. Suggest me how to move and which RA (either clinical or API-Pharma)is good from your end.
Regards
Pradeep
Hi Pradeep,
DeleteSince, you are having a valuable experience of API R & D, you could prefer API RA. Then, you could start reading about basics of RA (articles in regulatory one, will help on this aspects). Since, you are having about 6 years experience, I guess you have good no.of contacts for references to RA jobs.
For your other query regarding, Indian universities/institutes offering courses in RA, you could refer the link-
http://www.regulatoryone.com/2011/10/institutes-offering-regulatory-affairs_03.html
RAPS exam is something, which is taken by people who are having significant experience in RA . For details on RAPS, please refer RAPS website.
Hope, I clarified on all your queries.
Regards,
Rajesh
hi i did my microbiology and i want to make career in RA .one pune institute IPER suggest me to do first QA/QC and then pursue RA what you suggest me on that suggestion ?
ReplyDeleteHi Rajesh,
ReplyDeleteThanks a lot for your information on RA. I am interested in Regulatory affairs.I am M-Pharmacy fresher from Pharmaceutical Analysis and Quality Assurance department.Can you help me to enter into RA field.Is it required for me to do course in Regulatory affairs?. Even the openings now in various pharmaceutical industries are for experienced persons.Can you suggest me any websites or industry which opens for RA freshers? and also can Is it possible to enter into Government organization directly without experience in this field.
Hi Rajesh,
ReplyDeleteThanks a lot for your information on RA.
i have some confusions could you please send me your mobile number.
Hi Rajesh. You have my appreciation for a well written article. However , I do differ with you on few grounds particularly the ones in relation with QC/QA. This is not necessarily true. Every single document that you get in RA from the plant has signatures from plant RA (in case of change control history), QA personnel, QC personnel and AR&D. QA is heart of your CMC sections. They are ones that identify the Critical Quality Attributes and how controls influence the manufacturing process to ensure products to be delivered and QC guys assist them with routine testing (analysis) which are imperative to the quality. TOPRA a renowned body of regulatory professionals has published an empirical finding about a sample set of 200(? not really sure) regulatory professionals(you can find it out on their website) .Their study shows that only 17% of their sample set were directly admitted into RA. An overwhelming number came from R&D and QA. Because RA without basic understanding of what happens in the plant or lab is merely a desk job; nothing beyond it and you cannot progress. I have seen guys in the industry who cannot interpret a chromatogram but are able to compile the data to prepare a dossier. Indian tragedy !! One more thing regulations are not just limited to regulated markets as you have various other markets that include domestic, ROW and other semi regulated markets. You kinda overlooked other markets perhaps due o nature of your work So, your statement , can possibly become misleading to the new guys who are eager to join RA.
ReplyDeleteCheers!!