Executive Director Regulatory Affairs Neuroscience - REMOTE
The Executive Director Regulatory Affairs will develop the global regulatory strategy with expertise in the Neuroscience/CNS therapeutic area. This individual will have experience in leading project teams for the preparation of pre-IND, EOP2, pre-NDA, etc. briefing documents & meetings with the FDA. The Executive Director Regulatory Affairs will be responsible for IND and NDA documents and will develop regulatory strategy based on new or 505(b)(2) drug development principles, regulatory guidance documents, and by getting input from cross-functional team members. Provide pre-marketing and post-marketing project support Develop global regulatory strategy for compounds in development starting from IND/IMPD to NDA/MAA submissions using experience in regulatory affairs
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