Remote NDA Oncology Regulatory Affairs Consultant in Waltham

Location: Massachusetts

Compensation: To Be Discussed

Staff Reviewed: Thu, Oct 15, 2020

This job expires in 18 days

Remote Level: 100% Remote

Employer Type: Staffing Agency

Education Level: Bachelors, Masters, Doctorate

Job Summary

A staffing and recruitment agency has a current position open for a Remote NDA Oncology Regulatory Affairs Consultant in Waltham.

Must be able to:

  • Provide Regulatory leadership as well as operational oversight
  • Responsible for devising Regulatory strategy and implementing such strategy
  • Participate in review and approval of all clinical pharmacology and clinical study protocols and CSRs; ensures documents are filed with FDA

Skills and Requirements Include:

  • Requires a BS degree or equivalent with a Master’s degree or PhD preferred
  • Requires 10 years related experience within the biotechnology/pharmaceutical industry
  • 8 years of clinical regulatory experience or equivalent combination of education and experience
  • Must have successfully led submission and approval of an oncology NDA within the last 5 years
  • Work on a more recent oncology NDA is preferred