Regulatory Affairs Associate - I

Seattle, WA 98102

Posted: 12/11/2018 Employment Type: Contract Industry: Scientific Job Number: 5273

Our client is an American biotechnology company that researches, develops and commercializes drugs.

 

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
  • Onsite
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