Kelsey Msc. Email & Phone Number
Global Regulatory Affairs Executive Consultant @ Vi-Leon
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Kelsey Msc. Location
- Boston, MA, US
Kelsey Msc. Work
- Global Regulatory Affairs Executive Consultant @ (June 2026 - Present)
- Pathway Teaching Assistant for Quality Science Education and Mentor @ (August 2024 - Present)
- Sr. Director Regulator Affairs CMC- Principal Consultant- 1 @ (February 2026 - May 2026)
- Director of Regulatory Affairs @ (September 2023 - February 2026)
- Soccer Coach @ (July 2023 - December 2025)
- Associate Director Global Regulatory Affairs-CMC @ (July 2021 - June 2023)
- Manager Global Regulatory Affairs -Biological Vaccines-CMC and CDMO space- @ (October 2018 - June 2021)
- Regulatory Consultant @ (August 2018 - September 2018)
- Manager- Global Regulatory Affairs- CMC-Small Molecules and Biologics @ (February 2017 - August 2018)
- Specialist-Global Regulatory Affairs- Immunology- -Immuno-Oncology Pipeline) @ (June 2016 - February 2017)
- Sr. Associate- Global Regulatory Affairs-CMC @ (June 2016 - June 2016)
- Associate II- Global Regulatory Affairs- CMC @ (October 2013 - June 2016)
- Lead Compliance Investigator (CMC- Rare Disease Biologic) @ (January 2012 - June 2012)
- Bio-Process Associate (Clinical Operations- Biologic) @ (September 2011 - January 2012)
- Bio-process Associate (Clinical Operations-Biologic); (Formerly Genentech Oceanside Clinical Plant) @ (November 2008 - September 2011)
- Laboratory Technician @ (January 2007 - January 2008)
- International Volunteer Bogota Colombia @ International NYC YMCA Go-Global (January 2006 - January 2007)
- Bio-Process Associate (CMC Operations) @ (January 2005 - January 2006)
- Quality Control Associate @ Stonyfield Farm (January 2005 - January 2005)
Kelsey Msc. Education
- The London School of Economics and Political Science (LSE)
Certificate (Master of Bussiness Administration Essentials)
2021-2021 - Northeastern University
Master of Science (Pharmacy Administration and Pharmacy Policy and Regulatory Affairs)
2011-2014 - University of New Hampshire
Bachelor of Science (Nutrition Sciences)
2001-2005 - The London School of Economics and Political Science (LSE)
Master of Business Administration
Kelsey Msc. Skills
- 21 CFR Part 11
- Advising Clients
- Analytical Chemistry
- Aseptic Processing
- Aseptic Technique
- Biological & Vaccine Development- Cell & Gene Therapy Programs
- Biologics & Vaccine Regulatory Support
- Biologics, Vaccine Development & Cell & Gene Therapy
- Biopharmaceuticals
- Biotechnology
- Buffer Preparation
- CAPA
- CMC Regulatory Affairs
- CMC Regulatory Strategy
- Change Control
- Cleaning Validation
- Clinical Development
- Clinical Trials
- Column Chromatography
- Column Packing
- Comparability Strategy & Regulatory Risk Assessment
- Computer System Validation
- Consulting
- Cross-functional Partnerships
- Cross-functional Team Leadership
- Deviation Management
- Deviations
- Drug Development
- FDA
- FDA GMP
- GAMP
- GCP
- GLP
- GMP
- Global CMC Strategy
- Global IND and BLA/NDA Submissions
- Global Regulatory Compliance
- Global Regulatory Strategy
- Grading
- GxP
- HPLC
- Healthcare
- IND
- IND / BLA / NDA Lifecycle Management
- IND/BLA Submissions
- ISO 13485
- ISO 9001
- LIMS
- Lab Testing
- Leadership
- Leadership Development
- Life Science Industry
- Lifesciences
- Long Distance Running
- Manufacturing Change and Comparability Strategy
- Master Control
- Medical Devices
- Module 3 Development and Lifecycle Management
- Molecular Pharmacology
- Nutrition Education
- Oncology
- Pharmaceutical Industry
- Pharmaceutical Manufacturing
- Pharmaceutical process development
- Post Approval Change Management
- Product Lifecycle Management
- Project Management
- Protein Chromatography
- Publishing
- Purification
- Quality
- Quality Assurance
- Quality Control
- Quality System
- R&D
- Rapid Response
- Regulatory Affairs
- Regulatory Compliance
- Regulatory Requirements
- Regulatory Submissions
- SAP
- SOP
- SOP Writing & Quality Systems Support
- Standard Operating Procedure (SOP)
- Teaching
- Team Leadership
- Technical Transfers
- Technology Transfer
- Trackwise
- U.S. Title 21 CFR Part 11 Regulation
- Ultrafiltration
- V&V
- Vaccines
- Validation
- global reg
- Marathon
- Standard Operating Procedure Sop
- Standard Operating Procedure
Kelsey Msc. Summary
- Kelsey Msc., based in Boston, MA, US, is currently a Global Regulatory Affairs Executive Consultant at Vi-Leon. Kelsey Msc. brings experience from previous roles at Pathway for Patient Health, Boston Biodevelopment LLC, RCM Technologies, Life Sciences and Super Soccer Stars. Kelsey Msc. holds a 2021 - 2021 Certificate in Master of Bussiness Administration Essentials @ The London School of Economics and Political Science (LSE). With a robust skill set that includes 21 CFR Part 11, Advising Clients, Analytical Chemistry, Aseptic Processing, Aseptic Technique and more. Kelsey Msc. has 2 emails and 2 mobile phone numbers on RocketReach.
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