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
