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Sr Manager Regulatory Affairs

Posted: October 01, 2024
Salary:US$145000 - US$180000 per year
Location:Seattle
Job type: Permanent
Discipline:Life Sciences
Reference:234726_1727799411
Work Location:On-site

Job description

  • Provides CMC regulatory support and guidance to project teams for clinical development and post approval changes; defines CMC regulatory submission strategies during development and post approval.
  • Experienced with clinical trial (IND/IMPD/CTA) and marketing applications (BLA/NDA/MAA) filing requirements including content requirement, technical writing, and tracking timelines.
  • Works with technical departments in R&D/Operations/Quality to develop high quality submissions.
  • Prepares and manages submissions to filings and supports review by regulatory authorities.
  • Liaises with FDA and other regulatory authorities in written communication and participates in meetings on product development regulatory issues.
  • Stays current with regulations and regulatory guidance documents.
  • Responsibilities include preparing regulatory assessments of manufacturing changes, authoring department SOPs, etc.
  • Prepares and/or reviews labeling, biological product deviation reporting, lot distribution reports, IND safety reports, clinical/investigator documentation, or other reports, as needed.
  • Other duties as required.
  • May or may not manage direct reports.