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Regulatory Affairs Associate - I in Seattle, WA at Integrated Resources, Inc

Date Posted: 1/11/2019

Job Snapshot

  • Employee Type:
  • Location:
    Seattle, WA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:

Job Description

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