Brian Wildstein Email & Phone Number
Associate Director, Regulatory Affairs Strategy @ Mitsubishi Tanabe Pharma America
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Brian Wildstein Location
- New York, NY, US
Brian Wildstein Work
- 2024 -now Associate Director, Regulatory Affairs Strategy @
- 2017 -2024 Senior Manager, Regulatory Affairs - Strategy @
- 2007 -2016 Global Submission Manager @
- 2001 -2007 Submission Manager @
- 1999 -2001 Senior Associate, Regulatory Affairs @
- 1997 -1999 Regulatory Associate @ Unigene Laboratories
- 1995 -1997 Regulatory Affairs Associate @ Ohmeda PPD (Presently Baxter)
- 1993 -1995 Associate Scientist @ Anaquest, Inc. (Presently Baxter)
Brian Wildstein Education
- Penn State University 1990-1993
- Stony Brook University 1986-1990
Brian Wildstein Skills
- Regulatory Affairs
- Regulatory Submissions
- eCTD
- FDA
- Pharmaceutical Industry
- IND
- Regulatory Requirements
- Clinical Development
- Validation
- Clinical Trials
- GMP
- 21 CFR Part 11
- Drug Development
- Document Management
- GCP
- NDA
- Documentum
- CRO
- SOP
- Medical Devices
- Lifesciences
- CMC
- Change Control
- Pharmacovigilance
- GxP
- Computer System Validation
- Electronic Submissions
- NeeS
- Publishing
- MAA
- MRP
- DCP
- CP
- Document Lifecycle Management
- eTMF
- CSC XPress/Publisher
- DCM
- EMA
- Writing
- Substance
- Chemical
- Adobe Acrobat
- Chemistry
- Archival Research
- Clinical Research
- System Upgrades
- Customizations
- Digital Preservation
- Data Formats
- Business Administration
- Adoption
- Thesis
- Road
- Ndas
- u.s. Food and Drug Administration Fda
- Dynamics
- Canadian
- Toolbox
- ANDA
- Gateway
- Nds
- Multi User
- Management
- Design
- Electronic Common Technical Document Ectd
- Standard Operating Procedure Sop
- Desktop Computers
- Toxicology
- Row
- Publications
- Csc
- Human Resources
- Pennsylvania
- Compilation
- Drug Product
- Nitric Oxide
- Reaction
- 13c
- Languages
- System
- Cell
- Tests
- Reports
- Microsoft Office
- User Acceptance Testing
- Medicine
- Testing
- Intermediates
- Training
- Microsoft Publisher
- Supplements
- CTD
- Solution
- Documentation
- Product Development
- Distillation
- Investigation
- Liberty
- Letters
- Information Technology
- Jersey
- User Training
- Content Management
- Coordination
- GCC
- FIX Protocol
- Applications
- Imaging Software
- Home
- Environmental Impact Assessment
- IV
- Life Sciences
- Dossiers
- European Union
- Quality Assurance
- 1h Nmr
- Suite
- Clinical Data
- Marketing
- Maas
- Technical Support
- Forest
- Project
- Data Migration
- Paper
- Clinical Documentation
- Case Report Forms
- Development Planning
- Responsibility
- General Correspondence
- Injection Molding
- Packaging
- Project Teams
- Regulations
- Labelling
- International
- Intelligence
- Regulatory Operations
- HEV
- Work Allocation
- New York
- Electronics
- Combustion Analysis
- Materials
- Software
- Bulk
- Webtop
- Outlook
- Study Reports
- Annual Reports
- EMC
- Limits
- Organic Chemistry
- Pharmaceutics
- Business Process
- China
- Technical Files
- IR
- Meetings
- Amendments
- EMEA
- Consumer Healthcare
- NMR
- Cabinet
- Databases
- Electronic Common Technical Document
- u.s. Food and Drug Administration
- Standard Operating Procedure
Brian Wildstein Summary
- Brian Wildstein, based in New York, NY, US, is currently a Associate Director, Regulatory Affairs Strategy at Mitsubishi Tanabe Pharma America. Brian Wildstein brings experience from previous roles at Mitsubishi Tanabe Pharma America, GSK and Forest Laboratories. Brian Wildstein holds a 1990 - 1993 Penn State University. With a robust skill set that includes Regulatory Affairs, Regulatory Submissions, eCTD, FDA, Pharmaceutical Industry and more. Brian Wildstein has 4 emails and 1 mobile phone numbers on RocketReach.
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