Julie W Stiltner
Senior Manager, Regulatory CMC at National Resilience Inc.
- Role
- Cmc Regulatory Affairs Associate Director at 阿斯利康
- Location
- Hamilton, OH, US
- LinkedIn followers
- 500 followers
General Business & ManagementView LinkedIn profile
About Julie W Stiltner
Pharmaceuticals, Biotechnology, Biologics, Active Pharmaceutical Ingredients, Drug Products, Regulatory CMC,Module 3 Dossiers, New Product Registrations, Product Maintenance, Regulatory Strategies, International Registrations, Drug Master Files, MAA, NDA, Quality Assurance, Change Control
Experience
Cmc Regulatory Affairs Associate Director
Jul 2021 — Present · West Chester, OH, US
Skills
- German
- Validation
- Pharmaceutical Industry
- Sop
- Fda
- Regulatory Strategy Development
- Regulatory Affairs
- German to English
- Regulatory Submissions
- Ema
- 21 Cfr Part 11
- Nda Supplements
- Cmc Regulatory Affairs
- Change Control
- Nda
- Quality System
- Product Lifecycle Management
- European Markets
- Laboratory
- Ctd
- New Drug Applications
- Gxp
- Cmc
- Quality Assurance
- Gmp
- Biotechnology
- Maa Variations
- Clinical Trials
- Capa
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