Regulatory Affairs Manager
Trenton Metro Area, NJ
- Create health authority feedback tracking table to identify open/ closed issues and inform the strategy in the pre-NDA/ MAA meetings and dossier.
- Mine SBAs, labels, guidances/regulations to generate a review of precedent to compare our clinical data with other approved product labels as far as patient population, efficacy and safety.
- To put our data in context of approved products and guide the benefit/ risk discussions, labeling and how CTD summary documents are written (e.g. how data is presented, which analyses should be prioritized, etc)
- Support formatting and drafting of the USPI
- Work with the team to capture various options/ probabilities for indication/ claims/ limitations of use based on possible scenarios with the data and prior precedent
- Support pre-BLA and NDA meetings and help work with functional sub-teams on Q/A prep and create issue trackers
- Support filing evaluations/ gap assessments and alignment on probability of technical success (approval, labeling claims, post-marketing requirements).