Regulatory Affairs Career Guide and Counseling

Question: Can somebody tell me about work in Regulatory Affairs for a Pharmaceutical company? I am interested in changing careers to work in the Regulatory Affairs department of a Pharmaceutical company. Can anyone tell me what they do or what the nature of the work is?

Answer: MOSTLY LIAISE WITH VARIOUS GOVT AGENCIES/OFFICES AND BODIES FOR APPROVALS SUCH AS DRUG CONTROL AUTHORITY, POLLUTION CONTROL BOARD ETC.

Question: What is the best way to find regulatory affairs positions in pharmaceutical industry in Toronto, Canada? Im looking for a position in regulatory affairs in pharmaceuticals in Toronto, and there are not many ads around. Does anybody here work in the industry who could give me some info on where is the best place to find ads?

Answer: Contact this guy. He seems to have the low down on the industry as it stands today. His name is John Abramson. His book is very well researched and very revealing.

Question: What is the average salary for Drug Regulatory Affairs Associate in Melbourne? We have recently moved to Australia, and my wife is an experienced regulatory professional. Can you suggest what kind of salary can one expect for Regulatory Affairs Associate position in Australian Pharma Industry, especially Melbourne?

Answer: Depends on your wife's qualifications & if they are recognised here. I've never heard of this job title, but I'm not in the pharmacy industry. I suspect Australian regulations may be quite different. A good place to start would be with an employment agency that specialises in this industry, they'd be able to assess your wife's qualifications. They can be found in the broadsheet newspaper professional employment section under pharmacy or medical. Good luck! :-)

Question: What changes in regulatory affairs have been made at AstraZeneca? How do they develop a regulatory strategy? Any info would be greatly appreciated! I'm also curious about the structure of the dept...who reports to to who, how do they react to suprises, etc.? How is this going to improve their regulatory performance? Should I invest in them or someone else? Any info would be greatly appreciated! I'm also curious about the structure of the dept...who reports to to who, how do they react to suprises, etc.? What changes in regulatory affairs have been made at AstraZeneca? How do they develop a regulatory strategy?

Answer: Read their annual report - it's available from their website You should discuss investment in AstraZeneca with your broker.

Question: what is the role of regulatory affairs in pharma industries? Every pharma industry have RA department, it's quite comman,but i have only one month experience in process R&D ,So i want to know tha role of Regulatory affairs in pharma,

Answer: They submit the applications for new drugs and follow-on applications for additional indications for existing drugs. They also submit annual reports and other important compliance documentation to the FDA and other agencies regarding changes in process.

Question: Any information on a career in regulatory affairs? I am interested in knowing if it is an easy field to break into once I get my masters. Also, is it a rewarding career financially? Are there online programs available? If you are taking the program or have taken it, is it a challenging field?

Answer: A MS in a technical field regarding the following regulated industries may/may not make it easy to get into RA- * Pharmaceuticals * Medical Devices * In Vitro Diagnostics * Biologics and Biotechnology * Nutritional Products * Veterinary Products * Cosmetics Regulatory professionals are responsible for guiding these healthcare products through the approval process and onto the market. Or you might work in other regulated industries, such as transportation or utility. The Regulatory Affairs Professionals Society (RAPS) site is deep with content on RA.(1) Online courses, certificates, and degrees are offered. (Yahoo! search found 7,760,000 pages about regulatory affairs schools, so there are many paths to take, Sara. Another deep site is FDA's Office of Regulatory Affairs(2), which has a navigator bar across the top for links to the above catagories. Typical examples of RA work are in "Development & Approval Process (Biologics)" and "Guidance, Compliance & Regulatory Information (Biologics)" sections in Vaccines, Blood & Biologics(3). The "golden rule" for Regulatory Affairs is "If it hasn't been documented, it wasn't done." (Failure to document something could lead to shutting down a business.) I was involved in RA for five years; the work is dead-line driven., which can mean 14-hour and more workdays to complete a product submission package. The pay is good, but the position often is not seen by others as a "professional" one, such as an engineer or scientist or sales person. Often a RA specialist is a "cost center," not a "profit center," and may be more vulnerable to being laid-off (unlike the three previously mentioned). As they say- "do your homework" and you'll learn if RA is what you'd like to do. Best success!

Question: Is there anybody who can provide information about the career in regulatory affairs? If anybody who would kindly perhaps mentor or be an advisor and open to suggestions on how I would enter this field, please let me know? Your help is greatly apppreciated. I am not looking for help to find job, but rather a person for guidence and advise. Thank you.

Answer: That is exactly my background! There is a program at Northeastern University that I am attending right now. It is called the School of Professional Studies: Masters of Biologics, Devices, and Drugs Regulatory Affairs. It is a really wonderful program and I am well on my way to getting a job in the field. You can google "Northeastern School of Regulatory Affairs" and click the link for RAPS. You can see how to apply and get accepted into the program. You can email me if you got questions, I'd be glad to help.

Question: Who should I address a complaint to about DC's Department of Consumer & Regulatory Affairs? Everytime I call them with a question, or go there, the people are always so ROTTEN. They are getting paid to do a job but they get so angry when you (politely) ask them to do it. I want to write a complaint to someone!

Answer: Here is a link for you to leave feedback: http://app.dc.gov/apps/about.asp?page=at… Its not to complain about that specific department, but you can make general comments about DC government.

Question: i wish to get a job in med device and or pharma regulatory affairs. 11 yr exp in food regulatory. bs chem dg i am seeking a Regulatory affairs position with a Medical device or pharmaceutical compnay. All 11 years of my experience has been in food/flavoring industry. What is the best way i can enter medical device and or pharmaceutical industry? I have a BS degree in Chemistry and minor in Biochemistry. NY/NJ area.

Answer: Right now the job market in pharma is very tight. No one is hiring given the economy and the uncertainty of the election. In fact my company just laid off many in clinical dept. All you can do is make sure you have the skills necessary and apply for the positions. If you have an in with the company even better...use them.

Question: Can Person working in Validation can enter to Regulatory affairs if so how i need to approach?

Answer: Perhaps =]