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Associate Principal Scientist, Regulatory Chemistry, Manufacturing And Control - Product Lead
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- The Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned small molecule products in accordance with global regulations and guidance's, and Company procedures.
- The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for life-cycle maintenance submissions, original registrations, and post-approval changes.
- The Associate Principal Scientist may also support project team goals and organizational initiatives, on an as-needed basis.
- Execute regulatory strategies by leading the development, authoring, and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals, and responses to health authority questions per established business processes and systems.
- Manage execution of CMC documentation including post-approval supplements, annual reports, registration renewals, and responses to health authority questions per established business processes and systems.
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