Tuesday, 2 October 2012

How to get a job in the field of Regulatory Affairs ?

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 ,Q2Q3AQ3BQ3CQ6A 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. 
Resume -  
  • 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.

Networking Networking is an important tool for getting to know about any openings in the field of Regulatory Affairs. In the professional Networking sites like Linkedin, having your complete profile is very important. The following things are to be considered/taken note of, while setting up your 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 MisconceptionsI 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! 

  • 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.