Remote Regulatory Affairs Operations Director in Plano

Job ID: Available for Members

Location: Texas

Compensation: To Be Discussed

Staff Reviewed: Wed, May 20, 2020

This job expires in 14 days

Job Category: Management

Telecommute Level: Majority

Travel Requirements: Possible Travel

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Job Summary

A medical research company has a current position open for a Remote Regulatory Affairs Operations Director in Plano.

Candidates will be responsible for the following:

  • Overseeing compliant archiving of all regulatory documents with permissions in place for access
  • Utilizing systems and tools to ensure high quality, consistent submission content, QC, and publishing
  • Providing hands on leadership and management of the formatting and electronic publishing processes

Qualifications for this position include:

  • Participate in corporate and departmental meetings
  • Minimum of 5 years direct experience in eCTD publishing in the life sciences
  • minimum of 10 years of relevant pharmaceutical/biotechnology Regulatory Operations experience
  • Thorough knowledge of the drug development process
  • Managed regulatory deliverables at the project level
  • Must have solid foundation in science obtained through academics and business experience