Careers in Research, Science and Healthcare
Re: How to get into Regulatory Affairs | |
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Author: | Anonymous ChemistryGuy Reader
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| Date: | 06-15-10 06:42am |
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I got into Regulatory by blending 5 years of R&D with 5 years of bench level Quality Control. I have a Masters in Biochemistry and an MBA. I worked at FDA for a time as a Review Chemist, then springboarded back into industry heading up a Regulatory Affairs group at a big pharma. I am retired and just consult now.
R&D and Quality are 2 disciplines which use entirely different parts of one's brain. Data reporting requirements are far different. In the R&D world emphasis is placed on "what works." In the Quality world, the premise is that a process has been designed and vaidated to work. The process is subjected to regulatory approval. If the process doesn't work, then the process is deemed to be out of compliance. All data are reported in the Quality Control environment, not just the data that "worked."
You spoke of writing a QA Plan, so I am taking from that that you wish to emphasise Chemistry and Manufacturing Controls (CMC). This is my specialty as well. That said there are many specialties in RA: pre-clinical, clinical, toxicology/safety, biostatistics, process validation and scale-up CMC (pre-and post approval), labeling, packaging, ad copy, post approval adverse events reporting/safety.
In the generics world (and NDA/BLA world too, but in a different respect) regulatory also involves legal aspects of patent law, and in the clinical sense, demonstration of bioequivalence to the innovator.
Whether generic or innovator, there is the world of developing regulatory strategy -- positioning of product claims, timing of filings, meetings with regulatory bodies to obtain early opinions with regard to what will be approvable, suitable manufacturing metrics, or clinical study design and their endpoints.
Where timing is one's interest, and MS Project is one's passion, regulatory Project management sees to it that the regulatory strategy and filing process is a well-oiled machine that can hit deadlines -- after all, time is money, and we are in the business of science.
Further to that there's always the mechanics thereof: publishing, eCTD regulatory application platforms, regional filing requirements as informed by ICH guidances, et. al.
If your intersts truly lie in the area of regulatory affairs, you should settle on what areas of RA you'd like to specialize in and what areas you'd prefer to be a generalist. Join the Regulatory Affairs Professional Society (RAPS) then plan to study, take the exams they give periodically and qualify, holding a new credential as Regulatory Affairs Certified (RAC).
This path can help you to make that transistion from pure R&D to the more relevant regulatory affairs environment which you seek.
To be successful, however, academics and test taking will not be enough and will only get you so far. Experience in the practical, industiral pharmaceutical/biologics world with dollar-value deliverables will be essential to your regulatory career success.
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| Author: Anonymous ChemistryGuy Reader |
Jun 16, 2010, 07:04AM |
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To June 15 5:26PM
To June 15 6:42. Can you expand more on how to get into regulatory strategy? I am a CRA with 4 years of experience and am looking to transfer over. I would appreciate any suggestions
First of all one must understand that regulatory strategy isn't a discipline unto itself in RA like say CMC, or clinical study design, but it is an expectation common to each area of specialty in Regulatory Affairs.
You are a CRA with 4 years in the field. You have marshaled the accurate collection of data at study sites, trained investigators in protocols, and audited the integrity of data reporting. It is something which involves the basic mechanics of the clinical environment much the same way a bench chemist in a quality control lab employs the mechanics of his craft. Organizational levels in respective departments are about the same, and so is the pay typically.
Development of Regulatory strategy in the clinical context takes place at a level higher than mechanical level. The CRA executes a protocol which is the end-product of a regulatory strategy, whose ultimate goal is to obtain regulatory approval for marketing.
The pathway to entering regulatory strategy development is to excel at what you do in the field, to the point that you are called upon to lead others in a CRA management role. Your primary metric will be fulfilling timeline governed deliverables. Hit the timeline targets on or before schedule and with excellent work product and you will be seen as a credible contributor to the regulatory strategy forming process.
As I noted earlier, time is money. Regulatory strategy focuses on creating and maintaining the environment that obtains the fastest time investment-to-product approval so that your client or company that you work for can recoup its research costs (i.e., you) and build upon the investment profitably.
Add higher level business education to your academic portfolio. Regulatory strategy and business decisions which proceed from it are closely linked, because in the end it all has a dollar value. Simple fact is this: your employment value is measured either by how much you make for your client, or company, or how much you save your client in both time and money.
Regulatory strategy development above all involves employment of superior communication skills -- written and oral. You know: stuff like subject-verb agreement, spelling, proper tense, no mis-placed modifiers, no dangling participles... When positioning product claims, one must be able to persuade regulatory bodies of the credibility of those claims, that the stats are credible, that the study was adequately powered, etc.
Regulatory strategy development and its successful and timely execution gets you from point A (research) to point B (market approval) in the quickest and most scientifically/therapeutically credible way possible, and at the least cost.
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| Author: Anonymous ChemistryGuy Reader |
Jun 15, 2010, 05:26PM |
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To June 15 6:42. Can you expand more on how to get into regulatory strategy? I am a CRA with 4 years of experience and am looking to transfer over. I would appreciate any suggestions. |
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| Author: There''s hope for you! |
Jun 15, 2010, 08:30AM |
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Most of the phone calls I get are from recruiters want some one with oncology experience. Since there's such a great demand for knowledgeable individuals in oncology, I am certain you could secure a QA position in oncology. Just search biotech and pharma companies that are doing clinical studies in your area of expertise. Genzyme, Celegene, Amgen, and Genetech are just a few companies that are always looking for experienced people. Also, contact a few recruiters and inform them of your oncology experience. |
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| Author: Anonymous ChemistryGuy Reader |
Jun 16, 2010, 10:19AM |
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Thanks everyone for responding to my question. After reading your answers I realized that I forgot to mention one key information....The company I work for now is not a pharmaceutical company. It is a Bio/IT (although mostly IT), and they designed the system for the adverse effect reporting. They wanted to show that it conforms to the 21 CFR Part 11 and that is where I came in. I actually don't know any RA professionals personally and since I am no longer doing bench research, it seems even harder to get my foot in the doors! I do understand that I can't just "land" an RA position, but I am having a hard time finding a job in any aspect of regulatory/QA science to get started. |
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| Author: Bob Corbo |
Jun 15, 2010, 05:15AM |
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First off you're doing a lot of the right things, so be sure to keep at it because the years will accumulate quickly enough. Whenever an opportunity arises offer to assist with the routine paperwork, copying, filing, etc necessary with any agency correspondence. You already worked as an auditor for the reporting of sever adverse reactions so get involved with the more mundane periodic reports. And dont limit yourself to just new drug development, there as much regulatory work out there for commercial drug products and/or medical devices. Almost everything can be needed for a potential filing nowadays. Offer to help your associates with its agency submission, even if they only let you watch and learn. You mentioned 21 CFR Part 11 Electronic Records but also become familiar with Parts 312 IND, 314 NDA, 211cGMP and 814 Medical Devices when the opportunities present themselves.
The truth is almost nobody begins their career in Regulatory Affairs, ask any of your senior RA associates and youll learn they all started in some other department and then transferred their experience actually doing clinical studies, QA/QC, etc into submitting this documentation and obtaining agency approval. In my experience, the best RAers are those who actually know what their submitting and not just box checking someone elses work against the latest guidance document. |
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| Author: Anonymous ChemistryGuy Reader |
Jun 14, 2010, 01:58PM |
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You are right- you have the skills- you just need someone to give you the chance to get the experience. I would suggest looking into small CRO or small biotech environments. It may mean that you'll have to take a paycut for a few years, but they'll pay you back in experience. Don't restrict your search to only the obvious places.
Also, if you have any free time where you are now, ask to assist in regulatory affairs or shadow someone after hours. |
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| Author: Anonymous ChemistryGuy Reader |
Jun 14, 2010, 11:36AM |
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I have a PhD in Biochemistry and 10 years in basic cancer research. During my PhD I worked on new drug development. The new agent I helped characterize is currently in Phase II clinical trials. During my postdoc I worked on identification of novel biomarkers for early detection of breast and ovarian cancers.
Currently I work for a company where I have been tasked to create the Quality Assurance group, and to that extent I wrote a Quality Assurance Program Plan, prepared documentation needed to conduct internal audits, and also served as an internal auditor of a system for reporting sever adverse reactions. This required becoming familiar with 21CFR Part 11.
My goal is to enter the field of regulatory science, because I am interested not only in the science but also the policy and law behind the new drug development and approval process. Since I don't have RA experience, I have signed up for courses to learn the specifics of that role and to have a better grasp about approval of pharmaceuticals in the US.
So, my question is the following...What is the chance of someone like myself actually being considered for a job in regulatory affairs? All of the positions I have found require a number of years in the regulatory affairs. While I believe I have the background necessary to get into the field, I certainly don't have the years. I am a fast learner and actually love to take on new challenges. All my work required that I pay great attention to details and moreover, to be a team player. I have proven leadership skills, but I am not afraid to follow and learn from others.
Thank you! |
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