Job Summary

A clinical research company is filling a position for a Remote Senior Oncology Regulatory Affairs Manager.

Candidates will be responsible for the following:

• Managing the preparation and review of regulatory filings to support U.S. and international marketing applications
• Serving as the regulatory representative on project teams
• Managing regulatory timelines and providing strategic input

Required Skills:

• Bachelor’s Degree, or international equivalent from an accredited institution, in science or health related field
• Experience in pharmaceutical, biotechnology or device/diagnostics industry or an advance degree in lieu of a portion of experience
• 5-8 years progressive regulatory affairs experience with expertise in Oncology
• 2-5 years supervisory/management experience
• Regional regulatory experience required
• Demonstrated experience interacting with regional health agencies)