Actively seeking position as SVP and VP and Head of Regulatory Affairs
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David Mitchell Location
Fairhope, AL, US
David Mitchell Work
2025 -
now Actively seeking position as SVP and VP and Head of Regulatory Affairs @ Biotechnology Research
now Biotechnology Research
2023 -
2024 Senior Vice President of Regulatory Affairs @
2020 -
2023 Senior Vice President, Head of Regulatory @
2019 -
2020 Head of Regulatory Affairs @ Roivant Pharma
2017 -
2018 Vice President of Regulatory Affairs and Quality @
David Mitchell Education
The Johns Hopkins University
Master's Degree (Bioscience Regulatory Affairs)
2011
-
2014
Mississippi College
Bachelor of Science (B.S.) (Chemistry)
1975
-
1978
David Mitchell Skills
IND
NDA
Regulatory Affairs
FDA
Pharmaceutical Industry
GMP
Clinical Development
Biotechnology
Clinical Trials
Oncology
Sop
Regulatory Requirements
Quality System
Drug Development
GxP
Life Sciences
Biopharmaceuticals
Trials
Harmonization
Acr
Justice
Criminal Law
Congress
HIV
Timelines
Process Simulation
Gaps
Psoriasis
Documentation
Consulting
Quality Circle
Portfolio
Disease
HIPAA
Claim
Law Enforcement
Orlando
eCTD
Europe
Cardio
Binding
Communication
Schedules
Regulations
Anesthesia
Pda
Litigation
Advancement
Reports
Cbi
Small Molecules
Business Intelligence
International
Dimensional
Raps
Ctm
Regulatory Compliance
Import
News
Cross Functional Team Leadership
Impd
Messaging
Draft
Arterial
Technical Reports
Blind
Letters
Indications
Policies and Procedures Development
Labelling
Guidelines
Ash
Project Teams
Meetings
Oversight
Complaints
Clinical Support
Clinical Research
Pivotal
Marketing
Outsourcing
Perspectives
Operational Planning
Ama
Therapeutic Areas
Arthritis
Chemistry
Usa
Human Resources
Access Control
Training
Scientific Background
Business Expansion
Evidence
EMEA
Crohn's
Business Planning
Contractors
Multi Functional
Bench
Policy
System Monitoring
Ddmac
GI
Corporate Actions
Business Development
Diabetic
Cros
Hiring
CMC
Export
Operations
Privacy Regulations
Assessment
Sold
Renal
Deadline
Assembling
Cardiovascular
Diverse Groups
Austria
Biopharm
Informatics
Dallas
Manufacturing
Real Estate
Compliance
Redwood
Profit
Attainment
Phase
Executive Positions
Canadian
Auditing
Federal Acquisition Regulation
Mississippi
Contractual Agreements
Primary Focus
Substance
Clinical Operations
Public Speaking
FIX Protocol
Cystic Fibrosis
European Union
Treatment
Dentistry
Phase 1
International Research
Corporate Websites
Birmingham
Subsidiaries
Research
Business Operations
CMOS
Summit
San Diego
Medical Affairs
Compliance Matters
Investigator Brochures
Board of Directors
Allergic Rhinitis
Competitive Analysis
Driving
Dra
Canada
Reporting
Trading
Kellogg
Strategies
Specialty Pharmaceutical
Convenience
Data Collection
Commercial Real Estate
Central Nervous System
Development Programs
Ocd
French
Regulatory Agencies
Pharmacovigilance
Hospital Sales
Sourced
Nhl
Portugal
Packaging
Antibodies
APIs
Troubleshooting
Paris
ICH guidelines
Publications
Hypertension
Atlanta
Entrepreneurship
Philadelphia
GCP
Presentations
Collaborating
Report Writing
Process Improvement
Obtain
CTA
Google Groups
Biologics
Dia
Itp
Coordinated
Drug Product
Capital Equipment
Spectrum
Japan
Science
Liability
Product Development
Implications
C
Failure
Restful Web Services
Medical Devices
u.s. Food and Drug Administration Fda
American
Hematology
Spain
Apl
Dissolution
Study Reports
Strategic Planning
Manufacturing Operations
Execution
Sales
Safety
German
Switzerland
Japanese
Marketplace
Western Europe
Analgesia
Germany
Serving
Home
Pfizer
Lymphoma
Patient Outcomes
Resume
Italy
Clinical Protocols
Collaborative
Grants
Proposal Writing
Revenue
San Francisco
Start Ups
Strategy
Quality Control
Policy Development
Advertising
Competitive Advantage
Chemical
Project
Guidance
Expedited
Quality Assurance
Internal Audit
Policies and Procedures
Non Clinical
Forward Thinking
History
Management
Materials
HPLC
Pharmaceutics
Amendments
Medicine
Asthma
Sage Act
Chicago
Steering
Committees
Press Releases
Cell
GLP
Newsletters
Due Diligence
Ndas
Scientific
Nephrology
Phosphate
Distribution Center Operations
Joint Development
Conferences
Executive Development
Texas
Through Design
Pah
London
Civil Litigation
Budgets
R
Row
Negotiation
Bridge Inspection
Mergers and Acquisitions
Rheumatology
Instrumental
Applications
Arrangements
Legal
u.s. Food and Drug Administration
David Mitchell Summary
David Mitchell, based in Fairhope, AL, US, is currently a Actively seeking position as SVP and VP and Head of Regulatory Affairs at Biotechnology Research. David Mitchell brings experience from previous roles at Biotechnology Research, Verastem Oncology, Sumitovant Biopharma, Inc. and Roivant Pharma. David Mitchell holds a 2011 - 2014 Master's Degree in Bioscience Regulatory Affairs @ The Johns Hopkins University. With a robust skill set that includes IND, NDA, Regulatory Affairs, FDA, Pharmaceutical Industry and more. David Mitchell has 1 emails and 1 mobile phone numbers on RocketReach.
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