
Karla Cuevas
Seasoned pharmaceutical professional currently supporting clinical programs for developmental devices and combination products. Expertise in clinical and regulatory labeling... | New York City Metropolitan Area, New York City Metropolitan Area, United States
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Karla Cuevas’s Emails ka****@ta****.com
Karla Cuevas’s Phone Numbers No phone number available.
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Karla Cuevas’s Location New York City Metropolitan Area, New York City Metropolitan Area, United States
Karla Cuevas’s Expertise Seasoned pharmaceutical professional currently supporting clinical programs for developmental devices and combination products. Expertise in clinical and regulatory labeling for medical devices and combination products. Extensive experience in regulatory affairs/labeling (CCDS, TPP, US/EU/global). Medical Writing expertise(CSRs, Clinical Overviews, PBRERs, etc). Process development, improvement and integration. Project Manager with extensive outsourcing experience. Synthesis of isotope-labeled and unlabeled compounds. Synthesis of metabolites (glucuronides, acetates, etc.). Synthesis, analysis and purification of oligonucleotides and siRNAs (manual and automated). Synthesis, analysis and purification of lipid nanoparticles and other drug delivery systems. HPLC, UPLC, LC-MS, size exclusion and ion exchange chromatography method development, maintenance and troubleshooting.
Karla Cuevas’s Current Industry Vertex Pharmaceuticals
Karla
Cuevas’s Prior Industry
Merck
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Regeneron Pharmaceuticals
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Shire
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Takeda
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Vertex Pharmaceuticals
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Work Experience

Vertex Pharmaceuticals
Director, Regulatory Affairs Labeling
Sun Jan 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Takeda
Clinical Program Lead, Medical Device and Combination Products
Fri Nov 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Dec 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Takeda
Associate Director, Regulatory Labeling Strategy
Sun Apr 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Oct 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Shire
Manager, Regulatory Labeling Lead
Wed Jul 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Mar 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Regeneron Pharmaceuticals
Associate Manager, Regulatory Labeling
Sun Jun 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jun 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
Sr. Specialist/Manager, Global Product Labeling
Sat Sep 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jun 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
Associate Regulatory Writer, Global Product Labeling
Mon Mar 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Sep 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
Research Chemist
Thu Feb 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Mar 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
Staff Chemist
Thu Jul 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Feb 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time)