Joel Alvarez Email & Phone Number
Regulatory Records and Information Management Leader @ Kailera Therapeutics
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Joel Alvarez Location
- Newton, MA, US
Joel Alvarez Work
- Regulatory Records and Information Management Leader @ (March 2025 - Present)
- Global Regulatory Compliance, Operations and Labeling Leader @ Bill & Melinda Gates Medical Research Institute (October 2018 - March 2025)
- Sr. Director, Head of Regulatory Operations, Labeling and Compliance @ Takeda Vaccines Inc. (March 2014 - October 2018)
- Director, Global Regulatory Operations and Technology @ (June 2007 - March 2014)
- International Regulatory Affairs @ (June 2007 - June 2008)
- Global Regulatory Submissions Management @ (March 2005 - June 2007)
- Regulatory Operations and Technology @ (July 2003 - March 2005)
- Documentation and Regulatory Systems @ (April 1996 - July 2003)
Joel Alvarez Education
- Bill & Melinda Gates Medical Research Institute
- Northeastern University
Masters
- Southern New Hampshire University
Bachelors (Computer Science)
Joel Alvarez Skills
- eCTD
- Regulatory Operations
- 21 CFR Part 11
- Electronic Submissions
- ICH guidelines
- Regulatory Affairs
- Document Management
- Team Leadership
- Regulatory Submissions
- Pharmaceutical Industry
- Biotechnology Industry
- NeeS
- Project Management
- Process Improvement
- Document Lifecycle Management
- Regulatory Systems
- NDA
- MAA
- NDS
- IND
- CTA
- SOP development
- Mentoring Of Staff
- Software Implementation
- Industry Standards
- System Design
- Global Regulatory Compliance
- Regulatory Requirements
- Regulatory Guidelines
- Clinical Development
- GxP
- CTD
- Clinical Operations
- Standards Development
- Project Planning
- Pharmacovigilance
- Quality System
- Validation
- Matrix Management
- Database Design
- Cross-functional Team Leadership
- Publishing
- Quality Management
- Strategic Sourcing
- FDA
- Clinical Trials
- Operations
- Cross Functional Team
- Human Resources
- Business Strategy
- It Auditing
- Human Capital
- Submissions
- Document Lifecycle
- Business Continuity Management
- Biotechnology
- Cross Functional Team Leadership
- ICT
- Cio and Ciso Advisory
- Development
- Operations Management
- Global Regulatory
- Cybersecurity
- Regulatory
- IT Service Management
- Marketing
- Compliance
- Telecoms Regulation and Policy
- Cyber Law
- Social Media
- Strategy
- Microsoft Office
- Customer Service
- PowerPoint
Joel Alvarez Summary
- Joel Alvarez, based in Newton, MA, US, is currently a Regulatory Records and Information Management Leader at Kailera Therapeutics. Joel Alvarez brings experience from previous roles at Bill & Melinda Gates Medical Research Institute, Takeda Vaccines Inc., Shire Human Genetic Therapies Inc. and Shire Pharmaceuticals. Joel Alvarez holds a Bill & Melinda Gates Medical Research Institute. With a robust skill set that includes eCTD, Regulatory Operations, 21 CFR Part 11, Electronic Submissions, ICH guidelines and more. Joel Alvarez has 1 mobile phone numbers on RocketReach.
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Top Kailera Therapeutics Employees
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Manny Lazaro
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Maura Gavaghan
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Jeanine McBee
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Paul Burgess
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Paula Cloghessy
Chief People Officer
Boston, MA, US
Elizabeth Bearby
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Indianapolis, IN, US
Laurie Stelzer
Chief Financial Officer
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Douglas Pagan
Chief Financial Officer
Boston, MA, US
Scott Akamine
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Priya Nanduri
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