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Remote Senior Global Regulatory Submissions Manager

Job is Expired
Location: Nationwide
Compensation: Salary
Staff Reviewed: Wed, Sep 12, 2018
Job Category: Healthcare, Project Management
Weekly Hours: Full Time
Employment Status: Permanent
Employer Type: Employer
Career Level: Experienced
Education Level: Bachelors

Job Summary

A pharmaceutical company is seeking a Remote Senior Global Regulatory Submissions Manager.

Individual must be able to fulfill the following responsibilities:

  • Manage and ensure the timely delivery of submissions
  • Develop submissions operations management
  • Oversee the preparation, timelines, submission, distribution and archives

Applicants must meet the following qualifications:

  • Minimum of 4 years of previous industry experience
  • Bachelor's degree in scientific discipline
  • Proven expertise in global standards for eCTD and other submission formats
  • Experience in the USA and EU with many submission types
  • High degree of familiarity with FDA CFR, interpreting regulatory guidance and monitoring the regulatory environment

COMPLETE JOB DESCRIPTION

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