Showing 1-10 of 4,118
Showing 1-10 of 4,118
Manager Regulatory Submissions jobs

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Fresenius Kabi - Lake Zurich, IL

Oversees entire labeling function in Regulatory Affairs including:. Responsible for providing effective leadership to the Labeling function in Regulatory...

LEO Pharma - Parsippany, NJ

With regulatory intelligence. Promotional interactions and submissions. Manager/ Manager, US Regulatory. And for submission of those relevant pieces to OPDP....

Genpact Pharmalink - Boston, MA

5 years CMC regulatory experience. We will require support in preparing and reviewing CMC submission documents, QC checking other packages & GAP analysis....

Genpact Pharmalink - Princeton, NJ

Around 5 years CMC regulatory experience. We will require support in preparing and reviewing CMC submission documents, QC checking other packages & GAP analysis...

ZS Pharma Inc. - San Mateo, CA

Assist Commercial Regulatory in managing requests for expedited Regulatory reviews and 2253 submissions. This requires coordinating activities among Marketing,...

Jazz Pharmaceuticals - Philadelphia, PA

Support clinical development biostatistics with exploratory analyses necessary for submissions and regulatory queries....

Linkage Biosciences - South San Francisco, CA

RAPS Regulatory Affairs Certification or a Regulatory Affairs Certificate a plus. Coordinate and author documents and assemble all materials required for...

Sanofi - Cambridge, MA

In this capacity, the GRTL has regulatory accountability globally for the program, working with the Global Regulatory team (regions, Regulatory CMC, Regulatory...

AbbVie - Lake County, IL

Initiatives may span regulatory strategy and policy, labeling, advertising & promotion, registration management, submissions operations, CMC and/or global...

Mortara - Milwaukee, WI

Experienced in regulatory submissions for countries such as Canada, Europe, Australia, Japan, Brazil and others....


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