Regulatory Affair jobs in Tarrytown, NY

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CMC REGULATORY AFFAIRS MANAGER

Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with applicable...

CompanyKatalyst
AddressTarrytown, NY
CategoryInformation Technology
Job typeFull-Time
Date Posted 2 months ago See detail

CMC Regulatory Affairs Manager

Katalyst

Tarrytown, NY

Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with applicable...

Sr. Director of Quality Assurance and Regulatory Affairs

Dynarex Corporation

Montvale, NJ

$160,000 - $185,000 a year

Stay abreast of regulatory requirements and changes, ensuring the organization's compliance with local, national, and international regulations. Develop and execute regulatory strategies to facilitate product approvals and certifi...