Telecommute Senior Regulatory Affairs Submission Management Manager

Location: Texas

Compensation: To Be Discussed

Staff Reviewed: Thu, Nov 26, 2020

This job expires in 23 days

Job Category: Healthcare

Remote Level: Partially Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors

Job Summary

A medical research and drug development company is in need of a Telecommute Senior Regulatory Affairs Submission Management Manager.

Candidates will be responsible for the following:

  • Partnering with Program Management to ensure submission deliverables are incorporated and visible to all stakeholders
  • Ensuring hand offs and deliverables from vendor authoring community are on time and in line with the submission standard
  • Utilizing project management methodologies and tools to guide Regulatory teams in achieving operational excellence

Applicants must meet the following qualifications:

  • Willingness to travel to various meetings, including overnight trips
  • Bachelor’s Degree
  • 5+ years pharmaceutical industry experience
  • Substantial experience working within Regulatory Affairs with a fluent understanding of drug development
  • Demonstrated experience in leading decision-making within a cross-functional, cross-cultural, global team structure in a matrix environment