Links

General Career Links

• The Riley Guide - internet job search resources
• JobSmart - local job listings
• Career Builder Network

Online Magazines

• Science Magazine's Nextwave

Sciencewriting

• Society for Technical Communication, Berkeley Chapter
• UC Santa Cruz Graduate Science Writing Program

Entrepreneurship

• Kaufman Fellows Program

Regulatory Affairs (Many thanks to Lisa Bell for compiling this list.)

Regulatory Agencies:

Food and Drug Administration This is the starting point for the entirety of the FDA and all its subdivisions

• Center for Biologics Evaluation and Research (CBER)
• Center for Drugs Evaluation and Research (CDER)
• Center for Medical Devices and Radiological Health (CDRH)
  These are each subdivisions within FDA that regulate different types of industries. For example, biotech
  companies working on small drugs would be handled by CDER. Whereas companies making devices such as
  pacemakers or the like would be regulated by CDRH.
• If you really want to get a sense for what a timeline is like for the drug approval process take a look at www.fda.gov/cder/handbook/index.htm (although they don't specifically state it I've heard that the whole process can take 5+ years)

International Regulatory Agencies:

• The Regulatory Affairs Professionals Society web page (see below) has a list of links to regulatory agencies for
  other countries.
• British Institute of Regulatory Affairs (BIRA) Although this is a European organization it provides a basic explanation of the field of regulatory affairs as it applies to all countries.

Professional Societies:

• Regulatory Affairs Professionals Society
  I would say this is one of the more important organizations for regulatory professionals. In addition to
  providing training it is an important networking group for people who have already started or are trying to
  start a career in regulatory affairs (note: they have a bay area chapter which meets once every other month for
  lunch and a presentation) . Unfortunately, the prices for their classes and membership is quite
  expensive but one of their training coordinators has informed me that the people "in charge" have agreed to
  offer a student membership rate at some point in the near future which may help defray the cost of the training
  seminars and provide access to information and job listings. Another very important fact about this group is
  that they are the only ones to offer the Regulatory Affairs Certification -- a designation which is becoming
  increasingly recognized and requested by industry. The exam is offered once a year and it can be taken only
  AFTER having been employed as a regulatory affairs professional for a few years.
• American Medical Writer's Association This is another great group that provides training etc. Although you may think that medical writers is a specific group the title actually encompasses a number of different types of positions including regulatory affairs.
• Drug Information Association This group provides training and has a good newsletter (Drug Information Journal) which has interesting articles relating to regulatory affairs. They also have a job listings page although most of the positions listed I've noticed are for positions on the east coast or in the midwest. Another interesting point is that their membership is only $65/year -- much less expensive that most organizations.
• American Association of Pharmaceutical Scientists/Northern California Pharmaceutical Discussion Group
  This group provides monthly meetings in Millbrae which are open to students. This was may first foray into
  the world of networking and I thought it was a nice first experience because the people who attend are usually
  from a variety of positions in biotech (depending on the speaker) and its also very reasonably priced. For
  dinner and presentation its only $17 if you register in advance on the web. The other good thing about this
  group is that they bring in speakers from different areas of biotech -- so far I've seen speakers on everything
  from regulatory to effective presentations and basic research.

Other Education:

• Food and Drug Law Institute This group provides training for regulatory affairs professionals in addition to lawyers which tends to make their slant somewhat more legislative. However, the classes they offer are still very informative to anyone in regulatory. Although they are very pricey one way to get into a class "on a budget" is to go apply as a student which means that you get placed on a waiting list. If the class doesn't fill up you can attend for free!
• UC Berkeley Extension They offer a course called The Drug Development Process which brings in a number of industry people to discuss regulatory and intellectual property issues. Unfortunately this course if VERY expensive but its the
  only one I've found at Berkeley.
• UC Santa Cruz Extension They offer two certificate programs -- one in clinical trials design and management and the other on bioinformatics. Although the clinical trials one is not exactly the same as regulatory affairs sometimes companies look for knowledge of GCP (good clinical practices) and this program offers a course on just that.
• UC San Diego Extension (OSHA Training Institute) and (Specialized Certificate Program in Regulatory Affairs)
  UC San Diego Extension has excellent programs for OSHA certification (which is different from regulatory
  affairs but I think Chris Amy deals more with these types of things and I wanted to provide information
  regarding his area) and, as far as I know, the only certificate program in Regulatory Affairs on the West
  coast (I may be wrong on this). The catch is that the certificate program takes a full year to complete
  because there's required classes in the Fall and Spring semesters and I'm not sure how much the whole
  thing costs.
• Tufts Center for the Study of Drug Development If you're planning on going to the East coast Tufts University has a group that provides a three-day post-graduate certification course which is quite extensive but also VERY expensive (although if you explain that you're a student they may be able to negotitate a lesser price -- but you didn't hear it from
  me ;) ).

Job sites that I've found useful (I'm certain that this is not complete):

• www.careermosaic.com
• www.bioview.com
• www.symbiosinc.com
• www.rainfo.org
• www.diahome.org
  

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