In House Counsel Jobs California | JDHuntr 45698 Manager, Global Regulatory Affairs, NJ

To apply go to JDHuntr.com

*Prepare, review and file regulatory submissions of the CMC section such as full Part 2/CMC Technical Sections (INAD/NADA/MAA’s), variations, supplements, MCSR’s and responses to authorities questions.  *Provide support for local/international regulatory needs in alliance with global business objectives. *Provide guidance/direction/training to other departments relative to in-depth and current understanding of regulatory compliance, submission requirements, time lines or EMEA, U.S. and international regulatory expectations.

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