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Regulatory Affairs Manager

Trenton Metro Area, NJ

Post Date: 03/24/2017 Job ID: JN -032017-18667 Job Type: Regulatory - Scientific
Pharm D, MS, PhD or related advanced degree with 3+ years of experience in pharmaceutical Regulatory Affairs including BLA/ NDA, US Package Inserts, Labeling, and related filings,
  • 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).

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