Telecommute Regulatory Affairs Operations Associate Director in Plano

Job ID: Available for Members

Location: Texas

Compensation: To Be Discussed

Staff Reviewed: Wed, May 20, 2020

This job expires in 18 days

Job Category: Healthcare, Project Management

Telecommute Level: Majority

Travel Requirements: Possible Travel

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Senior Level

Education Level: Bachelors

Job Summary

A medical research and drug development company has an open position for a Telecommute Regulatory Affairs Operations Associate Director in Plano.

Must be able to:

  • Coordinate regulatory submissions
  • Oversee technical aspects for submissions
  • Serve as lead publisher for in-house publishing

Skills and Requirements Include:

  • BA/BS, MS, or PhD in relevant technical discipline
  • Extensive knowledge of IND/NDA/eCTD and other electronic requirements and guidelines
  • 8 years of highly relevant pharmaceutical /biotechnology experience in Regulatory Affairs
  • Experience in working with vendors in support of regulatory submissions
  • Knowledge and understanding of applicable global regulations
  • Solid computer and organizational skills