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
