Director, Regulatory CMC
Neurocrine Biosciences(27 days ago)
About this role
This role provides strategic Regulatory CMC leadership for assigned commercial products and development projects to ensure compliance with approved marketing applications and to drive timely preparation and approval of regulatory submissions (IND/CTA/MAA/NDA/BLA). The position partners across functions and with external stakeholders to translate regulatory requirements into development and approval strategies.
Required Skills
- Regulatory Strategy
- CMC
- Submission Preparation
- IND/CTA
- NDA/BLA
- Agency Interaction
- Project Leadership
- Stakeholder Engagement
- Manufacturing Liaison
- Analytical Judgment
+1 more
Qualifications
- BS/BA Degree
- Master's Degree (Preferred)
- PhD (Preferred)
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