Roman Bradel Email & Phone Number
Vice President, Regulatory Affairs @ Supernus Pharmaceuticals, Inc.
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Roman Bradel Location
- Washington, DC, US
Roman Bradel Work
- 2024 -now Vice President, Regulatory Affairs @
- 2023 -now Head of Regulatory Affairs @
- 2016 -now Senior Director of Regulatory Affairs @
- 2015 -2016 Executive Director of Regulatory Affairs @
- 2015 Director Regulatory Affairs @
- 2008 -2011 Associate Director - Global Regulatory Affairs @
- 2006 -2008 Director Quality Assurance and Regulatory Affairs @
- 2004 -2006 Project Manager - Pharmaceutical Development @
- 1999 -2002 Manager Quality Assurance and Regulatory Compliance @
- now Quality Assurance Manager - Strategic Quality Assurance @
Roman Bradel Education
- Technische Universität Berlin
Doctor Of Philosophy (Biotechnology, Philosophy)
1983-1992 - Technical University Berlin
Associates
1987 - Technical University Berlin
Bachelor Of Science
1987
Roman Bradel Skills
- GMP
- Regulatory Affairs
- FDA
- IND
- Biopharmaceuticals
- Quality Assurance
- Regulatory Submissions
- CAPA
- Change Control
- Pharmaceutical Industry
- GLP
- Sop
- eCTD
- Technology Transfer
- Biotechnology
- Drug Development
- Life Sciences
- Validation
- Clinical Trials
- 21 CFR Part 11
- Medical Devices
- Vaccines
- Oncology
- Regulatory Requirements
- Consulting
- Europe
- Suppliers
- Chemical
- Corrective Actions
- Berlin
- Chemistry
- Acting
- Phase Ii
- GxP
- Transdermal
- Market Research
- Dia
- Successful Track Record
- Site Management
- Thesis
- Conversant
- SEP IRA
- Quality Auditing
- Deviations
- Treatment
- Assessment
- Regulatory Compliance
- Cancer
- Microbiology
- CMC
- Texas
- Regulatory Agencies
- Management
- Briefing
- Design
- Regulatory Guidelines
- Modification
- German
- Route
- Contractors
- Cfr
- Resume
- Patents
- Impd
- Mouse
- Aseptic
- Auditing
- Data Storage
- Global Projects
- GAP
- In Process
- Hosting
- Source
- Coastal
- Public Speaking
- Labels
- Approvals
- Execution
- Drug Product
- Cros
- Capas
- Process Validation
- Biodefense
- System
- Czech Republic
- Ovarian
- Combination Products
- ISO 9001
- Strategy
- Supervision
- Declarations
- Strategies
- Revision
- Drug Delivery
- Testing
- GCP
- ASQ
- Training
- Trending
- Supplements
- Supplemental
- Root Cause
- Fast Track
- Project Management
- Product Development
- American
- Research
- Quality Control
- System Monitoring
- Informatics
- Reporting
- Process Engineering
- Physical Chemistry
- Commercial Real Estate
- Investigation
- EMA
- LIMS
- R&D
- Analysis
- Inspection
- Written
- Advertising Agency
- Combination
- Raps
- Business Partnering
- Cash Flow
- Trials
- Houston
- C
- Improving Efficiency
- Computer System Validation
- Emergent
- Polish
- FIX Protocol
- Chemical Engineering
- Applications
- Regulatory Filings
- Debate
- Assay Development
- Communication
- Detail
- Negotiation
- Blas
- Efficacy
- Regulatory Risk
- European Union
- Water Treatment
- Scientific
- Licensure
- Operations
- Biopolymers
- OOS
- Quality System
- Risk Assessment
- Marketing
- EDRMS
- ISO 14001
- Maas
- Project Planning
- Project
- Contractual Agreements
- France
- Facilities Management
- Thinking
- Written Communication
- Computer Proficiency
- Spain
- Responsibility
- Internal Audit
- ISO 13485
- Six Sigma
- Means
- Therapists
- Regulations
- Distribution
- International
- Starch
- Small Molecules
- Germany
- Start Ups
- Reviews
- Electronics
- Guidelines
- Bridge Inspection
- Compliance
- Arizona
- Deer
- Api Manufacturing
- CMOS
- Pharmaceutics
- Good Manufacturing Practice Gmp
- Manufacturing
- Biologics
- Arranging
- Professional Background
- International Management
- Optimization
- Due Diligence
- Risk
- Problem Solving
- Pre Approval
- Filing
- Meetings
- Global Regulatory Compliance
- Research Projects
- French
- Mock
- Evaluation
- Commercialization
- Product Quality
- Good Manufacturing Practice
Roman Bradel Summary
- Roman Bradel, based in Washington, DC, US, is currently a Vice President, Regulatory Affairs at Supernus Pharmaceuticals, Inc.. Roman Bradel brings experience from previous roles at Tosk, Inc., Prolacta Bioscience, Newlink Genetics and Abbvie. Roman Bradel holds a 1983 - 1992 Doctor Of Philosophy in Biotechnology, Philosophy @ Technische Universität Berlin. With a robust skill set that includes GMP, Regulatory Affairs, FDA, IND, Biopharmaceuticals and more. Roman Bradel has 3 emails and 2 mobile phone numbers on RocketReach.
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