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