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National Institute of Mental Health
Rockville, Maryland
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Regulatory Affairs Specialist
You will primarily assist in the preparation of regulatory submissions for AgNovos’ lead product to ensure compliance with regulatory requirements in the EU, US FDA, and regulatory bodies in other countries. Working with both internal teams and external consultants, you will provide overall regulatory support, including but not limited to FDA meeting preparations, archiving documentation, making entries into and maintaining the regulatory database and file storage system. Additional responsibilities may include regulatory support for Manufacturing/Operations and Quality Assurance primarily in the area of regulatory compliance, document and records management. A successful individual in this role will need to be highly organized with attention to details. Essenti
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