Remote Regulatory Affairs Oncology Focused Senior Manager

Job ID: Available for Members

Location: Nationwide

Compensation: Salary

Staff Reviewed: Wed, Nov 20, 2019

Job Category: Healthcare, Project Management

Telecommute Level: Majority

Travel Requirements: Possible Travel

Weekly Hours: Full Time

Employment Status: Permanent

Employer Type: Staffing Agency

Career Level: Experienced

Education Level: Bachelors

Job Summary

A staffing agency is searching for a person to fill their position for a Remote Regulatory Affairs Oncology Focused Senior Manager.

Candidates will be responsible for the following:

  • Assisting in the preparation and review of regulatory filings
  • Reviewing clinical trial documents
  • Preparing submissions and oversee the maintenance of regulatory filings

Skills and Requirements Include:

  • Travel may be required up to 25%
  • 5-6 years progressive regulatory affairs experience
  • Bachelor's degree, or international equivalent from an accredited institution
  • 8 years' experience in a CRO, pharmaceutical, biotechnology or device/diagnostics industry
  • Knowledge of regulatory requirements, including ICH and FDA
  • Demonstrated experience in preparation and maintenance of INDs and support of NDAs and/or BLAs