- Lead end-to-end CMC strategy across drug substance, drug product, and analytical development—from early-stage evaluation through regulatory submission and commercial launch with a focus on scientific aspects.
- Drive regulatory excellence by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines.
- Prepare product development plans from early development through Phase 4.
- Manage and lead direct reports through development and performance management and by providing training on current and new regulatory requirements.
- Perform other scientist related duties, as needed.
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