- Boehringer Ingelheim (Ridgefield, CT)
- …* Act as a company liaison with the US Food and Drug Administration . * Research information on regulatory CMC standards and departmental policies. * Provide ... Review Team (PLRT) and in collaboration with US RA Labeling Content, provide CMC regulatory support during...Pharmacy program Fellow should have basic understanding of: + Food , Drug and Cosmetic Act. + 21 CFR regulations… more
- Boehringer Ingelheim (Ridgefield, CT)
- …clinical trial design and results, if available, taking into account US regulatory labeling precedence and FDA comments/guidance. + Pre-evaluations and External ... Regulatory Strategy Document. + In cooperation with US/Global Labeling , provide project-related US regulatory input into...+ Act as a company liaison with the US Food and Drug Administration . + Provide analysis,… more