Director, Regulatory Affairs
Neumora(1 month ago)
About this role
The Director, Regulatory Affairs at Neumora will lead regulatory strategy and filing activities across early to late-stage development programs to maximize chances of successful and timely product registration. This role represents Regulatory Affairs on multidisciplinary teams, communicates regulatory risk and strategy to senior leadership, and interacts directly with FDA and other global health authorities. The position supports preparation and submission of high-quality, compliant regulatory dossiers and contributes to company and departmental initiatives.
Required Skills
- Regulatory Strategy
- Cross-Functional
- Submission Preparation
- Risk Communication
- Regulatory Review
- Agency Interaction
- Document Review
- Team Leadership
- Vendor Management
- IND/CTA Filings
+2 more
Qualifications
- B.S./M.S. in Scientific Discipline
About Neumora
neumoratx.comNeumora Therapeutics is a neuroscience-focused biopharmaceutical company pioneering a new era of precision medicines to restore brain health and wellbeing. The company develops targeted therapies for neurological and neuropsychiatric disorders by integrating human brain biology, genetics, biomarkers, and translational clinical models to improve patient selection and outcomes. Neumora partners with academic and industry collaborators to advance a pipeline of precision neurotherapeutics designed to address unmet needs in brain disease.
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