Telecommute Quality Clinical Regulatory Affairs Senior Program Manager in Lexington

Job ID: Available for Members

Location: Massachusetts

Compensation: To Be Discussed

Posted: Thursday, February 15, 2018

Job Category: Consulting, Project Management

Telecommute Level: Majority

Travel Requirements: Some Travel, Possible Travel

Employment Status: Independent Contractor

Employer Type: Staffing Agency

Career Level: Manager

Education Level: Bachelors

Job Summary

A staffing agency has an open position for a Telecommute Quality Clinical Regulatory Affairs Senior Program Manager in Lexington.

Candidates will be responsible for the following:

  • Providing regulatory expertise and guidance
  • Formulating regulatory labeling strategies
  • Preparing submission-ready labeling components

Position Requirements Include:

  • Bachelor's degree in a scientific discipline or closely related field is required
  • 5-7+ years of regulatory experience in the pharmaceutical/biotechnology industry; clinical experience considered
  • detailed understanding of pharmaceutical drug development and global regulations pertaining to labeling
  • Expertise in developing CCDSs
  • Knowledge of global guidance relevant to labeling, drug development, and commercialization of prescription medicines
  • Expertise in EU and US labeling requirements/ guidance and familiarity with US legacy and PLR-formatted labeling