Analytical Regulatory Author & Strategist (R4 - R5 Level) (Secondment - 12 Months)
USA - MO - St Louis 875 Chesterfield, United States
USD 106K-176K (estimate) Senior-level Full Time
Tasks
- Align analytical sections with regulatory strategy
- Author analytical Module 3 sections for regulatory submissions
- Develop analytical strategies and CTD template guidance
- Develop and refine ARD regulatory strategy
- Identify and implement AI and digital technologies for regulatory authoring
- Integrate analytical data into regulatory narratives
Perks/Benefits
- N/A
Skills/Tech-stack
AI | Analytical Control Strategy | Analytical Development | Biologics | CTD | Comparability | Control strategy | Data Interpretation | Generative AI | Method Development | Process Development | Regulatory strategy | Stability Testing
Education
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