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
