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Remote Biologic Technical Documents Regulatory Affairs Specialist in Boston

Job is Expired
Location: Massachusetts
Compensation: To Be Discussed
Staff Reviewed: Mon, Jan 27, 2020
Job Category: Healthcare, Information Technology
Weekly Hours: Full Time
Employer Type: Staffing Agency
Career Level: Experienced
Education Level: Bachelors

Job Summary

A staffing company is seeking a Remote Biologic Technical Documents Regulatory Affairs Specialist in Boston.

Individual must be able to fulfill the following responsibilities:

  • Provid regulatory guidance for development projects, post-approval CMC changes/variations
  • Author/review/approve CMC technical documents

Skills and Requirements Include:

  • Bachelor's Degree
  • Technical writing experience and/or CMC/Regulatory writing experience
  • Must have working knowledge of GMPs
  • Must have working knowledge of biologic/drug regulations (FDA, ICH, EU, etc.) related to CMC
  • Prior regulatory experience is required
  • Experience with drug/biologics licensure

COMPLETE JOB DESCRIPTION

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