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.

Sr Manager Regulatory Affairs