US-, CMC Manager 452431232983-MZ
|Our client is a world-leading animal health company|
-Incumbent is accountable for new products and/or marketed products support as it pertains to the CMC technical sections of our client’s FDA regulatory filings.
-Daily work within new product development, maintenance of approved products, including but not limited to finished product and drug substance, site transfers and in line extensions.
-Regular adherence to FDA regulations, guidelines, policy changes, and technical issues pertaining to US and International Laws
-Preparation and review of submissions of CMC section such as full Part 2/CMC Technical Sections (INAD/NADA/MAA’s), variations, supplements, MCSR’s and responses to authorities questions
-Performs EMEA, U.S. and international regulatory research tasks as requested.
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