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Nederlands
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Katherine K
@katherinekalait
Virtual AdministratoR, Business Content Editor, Document Formatting Specialist
Verenigde Staten
Engels
Over mij
Hello! I’m Katherine Kalaitzidis, a regulatory affairs and document specialist with extensive experience supporting pharmaceutical and biotechnology organizations. I specialize in CMC documentation, regulatory submissions, document formatting, quality control, proofreading, data verification, and submission document management. My experience includes working with clinical, nonclinical, and CMC regulatory documents, collaborating with cross-functional teams, maintaining submission trackers, and ensuring documents meet formatting, consistency, and quality requirements.
Skills
Katherine K
offline •
Gemiddelde reactietijd: 1 uur
Bekijk mijn diensten
Templatedocumenten en opmaak
I will format edit and design microsoft word document
Templatedocumenten en opmaak
I will microsoft word document formatting and design
Werkervaring
QC / Medical Editor / Document Specialist
Therapeutes magazine • Fulltime
Oct 2020 - Present • 5 yrs 11 mos
Supported clinical, nonclinical, and CMC regulatory documentation across temporary projects for major biotechnology and pharmaceutical organizations. Key responsibilities included: Drafting cover letters and completing regulatory submission forms. Reviewing regulatory documents for content, grammar, formatting, bookmarking, and consistency. Comparing documents against source materials, including text, tables, and graphs. Identifying formatting and quality issues and providing feedback to cross-functional teams. Maintaining Excel trackers for regulatory activities. Managing documents within document-management systems. Conducting document searches and creating reports. Collaborating with teams to obtain source documents and establish submission deadlines. Supporting the development and improvement of document-management practices. Working with Documentum and Veeva/RIMS systems.
CMC Regulatory Affairs Associate II
Gilead Sciences • Fulltime
Dec 2014 - Present • 11 yrs 9 mos
Supported regulatory submission activities for pharmaceutical development programs and served as a point of contact for U.S. CMC regulatory activities. Key responsibilities included: Supporting regulatory submissions from preparation through completion. Serving as U.S. regional lead for selected development programs. Developing and communicating regulatory strategies. Coordinating U.S. submission preparation activities. Collaborating with authors and reviewers. Supporting IND amendments and Annual Reports. Facilitating regulatory review and approval activities.
