Katalyst Healthcares & Life Sciences
Location: Swiftwater,PA, USA
Date: 2024-11-19T08:42:33Z
Job Description:
Responsibilities:
- 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 labelling, biological product deviation reporting, lot distribution reports, IND safety reports, clinical/investigator documentation, or other reports, as needed.
- May or may not manage direct reports.
Requirements:
- bachelor's degree in a scientific discipline or equivalent.
- 7 years of related experience in FDA regulated industry.
- At least 3 years of experience in CMC regulatory affairs.
- Experience with biologics required cellular therapy experience strongly preferred.
- Experience with eCTD electronic documents and submissions.
- Knowledge of cGMP/ICH/FDA regulations.