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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.