Delcath Systems · 20 hours ago
Senior Manager, Regulatory Affairs, CMC
United States
Full-time
Remote
Senior LevelDelcath Systems is seeking a Senior Manager, Regulatory Affairs, CMC who will be responsible for executing the day-to-day tactical activities of regulatory submissions for their oncologic drug/device combination product. The role involves ensuring compliance with FDA and EU regulations while working closely with the regulatory team to prepare and submit necessary documentation.
BiotechnologyHealth CareOncologyPharmaceutical
Responsibilities
Must be familiar with the Quality Systems Registration under 21 CFR 820, Regulation of Combination Products 21 CFR 4, and EU Medical Device Regulation (MDR)
Must have knowledge of Investigational New Drug regulations under 21 CFR 312 and Applications for FDA Approval to Market a New Drug regulations under 21 CFR 314
Must have device product experience, drug/device combination product experience a plus
Must be familiar with FDA’s current thinking and guidance for industry
Execute day-to-day processes for regulatory accountabilities to ensure continual regulatory compliance with FDA and MDR requirements
Work closely with regulatory team and internal staff to prepare, review and submit international regulatory and domestic submissions. These shall include submissions for NDA, IND and CTA supplements and amendments thereof
Assist in the preparation, review, and submit annual reports, amendments and supplemental applications to INDs, NDAs, and CTAs
Monitor, review and interpret new or revised regulatory requirements and proactively advise corporate disciplines
Must be able to review and interpret technical and scientific data to ensure regulatory requirements are met; evaluate product/design and process changes for potential effect upon product safety and effectiveness; and appropriately document the regulatory disposition of such changes
Other activities as assigned by management
Qualification
Required
Must be familiar with the Quality Systems Registration under 21 CFR 820, Regulation of Combination Products 21 CFR 4, and EU Medical Device Regulation (MDR)
Must have knowledge of Investigational New Drug regulations under 21 CFR 312 and Applications for FDA Approval to Market a New Drug regulations under 21 CFR 314
Must have device product experience, drug/device combination product experience a plus
Must be familiar with FDA's current thinking and guidance for industry
Execute day-to-day processes for regulatory accountabilities to ensure continual regulatory compliance with FDA and MDR requirements
Work closely with regulatory team and internal staff to prepare, review and submit international regulatory and domestic submissions. These shall include submissions for NDA, IND and CTA supplements and amendments thereof
Assist in the preparation, review, and submit annual reports, amendments and supplemental applications to INDs, NDAs, and CTAs
Monitor, review and interpret new or revised regulatory requirements and proactively advise corporate disciplines
Must be able to review and interpret technical and scientific data to ensure regulatory requirements are met; evaluate product/design and process changes for potential effect upon product safety and effectiveness; and appropriately document the regulatory disposition of such changes
Company
Delcath Systems
Delcath Systems is an interventional oncology company that focuses on the treatment of metastatic liver cancer.
Founded in 1987
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$292.9MKey Investors
Vivo CapitalAvenue Capital GroupSilicon Valley Bank
2024-12-30Post Ipo Equity· $16.3M
2024-03-15Post Ipo Equity· $7M
2023-09-01Post Ipo Equity· $35M
Leadership Team
G
Gerard J. Michel
Chief Executive Officer
Martha Rook
Chief Operating Officer
Recent News
Business Wire
2026-01-11
2026-01-11
BioWorld Financial Watch
2026-01-04
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