XPost: tor.jobs, ont.jobs   
   From: careers@jedgarcareers.com   
      
   Regulatory Affairs Associate  -  $60-70K plus Bonus   
      
   We are currently seeking a Regulatory Affairs Associate for a leading   
   Pharmaceutical   
   firm located in Toronto.   
      
   As a Regulatory Affairs Associate you are responsible for; File drug   
   product submissions for Canada and the U.S. (e.g. DMFs, ANDS, NDS, ANDA,   
   NDAs,  S/NDSs, DINs, CTAs, NCs, INDs, provincial formulary submissions   
   etc.), for the successful registration of domestic and international   
   drugs and devices, as assigned.  As RAA, obtaining approval of drug   
   product submissions by preparing written responses to deficiency letters   
   from regulatory agencies is crucial.  You will also obtain approval of   
   changes to approved drug products for FDA (CBE supplement, PAS) and TPD   
   (Notifiable Change)and maintain approved drug products for FDA (Annual   
   Report) and TPD (Annual Drug Notification).  Assisting in preparation   
   and completion of FDA and TPD pre-approval and GMP inspections is also   
   part of the role.   
      
   In consultation with the manager, the RAA provides regulatory guidance   
   and expertise to US, Canada, Israel, International Sales & Marketing,   
   R&D, QC/QA, and Operations.   
   Reviewing internal documentation (labeling, master batch records,   
   specifications) and external documentation (clinical reports) for   
   adherence to regulatory guidelines is also   
   part of the work as is; Assisting global drug product registrations,   
   Maintaining regulatory library and Assisting the Manager of Regulatory   
   Affairs as required.   
      
   You must have; Minimum B.Sc. in Chemistry, Pharmacy or Life Science and   
   at least three years of experience in Regulatory Affairs, expertise in   
   chemistry and manufacturing, labeling and format requirements for drug   
   product registration for FDA (ANDA, NDA, DMF, IND) and TPD (CTA, ANDS,   
   S/ANDS, NDS, DIN, DMF), knowledge of GMP requirements and QA/QC   
   procedures, excellent interpersonal, written and verbal communication   
   skills as well as good computer skills, ability to plan, coordinate and   
   work effectively in a team-oriented environment.   
      
   We are looking for a good problem solver with the ability to prepare   
   written responses to deficiency letters from regulatory agencies as this   
   aspect of the work requires the most attention to detail, as well as   
   obtaining approval of changes to approved drug products.   
      
   Salary is $60-70K with full benefits and a bonus plan.   
      
   Call Jason Edgar at 416 225-2628 and check us out at;   
   http://www.jedgarcareers.com   
      
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