Regulatory Affairs Associate - I : 18-05454

Seattle, WA 98102

Posted: 01/16/2019 Job Category: Clinical Affairs Job Number: 11668264
Akraya is looking for a Regulatory Affairs Associate for one of our clients. If the job description below is a fit, please apply directly or call Sherwin Gardner at 408-338-6119.If this position is not quite what you’ re looking for, visit akraya.Com and submit a copy of your resume. Our recruiters will get to work finding you a job that is a better match at one of our many clients.
 
Primary Skills: Document Filing, Tracking, Indexing, Retrieving. Regulatory & Training skills and ICH requirements
Duration: 12 Months
Contract Type: W2 only
 

Responsibilities:
  • Provides support in the preparation of regulatory submissions for investigational and commercial products in line with ICH requirements, regional requirements, and scientific and company policies and procedures.
  • Works to develop and acquire required regulatory skills and knowledge, with guidance from immediate manager.
  • May contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.
  • Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs.
  • Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department.
  • Seeks assistance from appropriate internal and external resources.
 
Knowledge and Skills:
  • Good organizational skills and ability to work on a number of projects in alignment with timelines.
  • Strong verbal and written communication skills and interpersonal skills.
  • Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas.
  • May act as a resource on a specific topic for other Regulatory personnel within the department.
  • Work is performed under the supervision of Regulatory Affairs professionals following detailed instruction with well-defined procedures
 
Education and Experience:
  • 2+ years of relevant training or industry experience with BS/BA
  • 1+ years relevant training or industry experience with advanced degree
  • Degree in a scientific field is preferred
 
   Please apply directly with your updated resume or call Sherwin Gardner at 408-338-6119
 
About Akraya:
Akraya, Inc. Is an award-winning staffing firm that works with many of the leading, technology-based companies around the world. We have been ranked as one of the “ Best Staffing Firms to Temp for” by Staffing Industry Analysts on multiple occasions and are a preferred staffing vendor within numerous staffing programs. Please visit akraya.Com to search through all of our current openings or to submit your resume to our recruiting team.

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