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

Vice President, Regulatory Affairs @ (March 2024 - Present)
Head of Regulatory Affairs @ (March 2023 - Present)
Senior Director of Regulatory Affairs @ (August 2016 - Present)
Executive Director of Regulatory Affairs @ (September 2015 - August 2016)
Director Regulatory Affairs @
Associate Director - Global Regulatory Affairs @ (September 2008 - September 2011)
Director Quality Assurance and Regulatory Affairs @ (July 2006 - June 2008)
Project Manager - Pharmaceutical Development @ (June 2004 - July 2006)
Manager Quality Assurance and Regulatory Compliance @ (August 1999 - October 2002)
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.