associate director global regulatory affairs at iqvia@ IQVIA
Lancaster, Pennsylvania, United States
Lisa Spigelmyer
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Ursinus College
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FlashIntel GPTLisa Spigelmyer is a regulatory professional with over ten years of experience in Regulatory Affairs. She has extensive experience managing the development of new drug products through pre-IND, IND, and NDA processes. Lisa is highly skilled in CMC aspects of drug development, including technical writing of Module 3 and 2.3. She is adept at navigating the complex regulatory landscape and developing accurate submissions. Lisa has worked in various roles within the FDA, including Associate Director of Global Regulatory Affairs and Quality Assurance at IQVIA and Senior Manager of Regulatory Affairs and Quality Assurance at DJA Global Pharmaceuticals Inc.
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About
Regulatory professional with over with over ten years of experience in Regulatory Affairs. Extensive experience in managing the development of new drug products through the pre-IND, IND, and NDA processes to support marketing approval by FDA. Highly experienced in CMC aspects of drug development including technical writing of Module 3 and 2.3. Adept at navigating the complex regulatory landscape to develop accurate submissions, which stand the test of FDA scrutiny, leveraging experience within several different divisions of the FDA.
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associate director global regulatory affairs at iqvia
Hospitals and Health Care
Lisa Spigelmyer's Professional Milestones
- Associate Manager Quality Compliance (2013-01-01~2013-07-01): Improving quality control processes resulting in enhanced product consistency and increased customer satisfaction.
- Quality Specialist (2010-02-01~2012-06-01): Enhanced product quality to drive customer satisfaction and surpass production standards.
Education
Chemistry,
Bachelors,
Bachelor Of Science
2004-2008Skill
Fda
Uv/vis
Capa
Gmp
Quality Control
Quality Assurance
Validation
Root Cause Analysis
Quality System
Chemistry
Microsoft Office
Laboratory
21 Cfr Part 11
Hplc
Research
Lifesciences
Microsoft Excel
Design Control
V&v
Sds Page
Powerpoint
Pcr
Data Analysis
Certification
Colleagues
Leandro Sergio
team leader l process owner l scrum l agile l business analyst l customer success l analista de contratos l billing
Brett Clemmer
product owner at cenduit
Samyuktha BR
Product Owner
Ian Walsh
engineer | entrepreneur | musician | business owner
Ender Özkanal
Product Owner
Other Named Lisa Spigelmyer
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Lisa Spigelmyer's social media include: Linkedin,
Lisa Spigelmyer works for IQVIA
Lisa Spigelmyer's role in IQVIA is associate director global regulatory affairs at iqvia
Lisa Spigelmyer works in the industry of Hospitals and Health Care
Lisa Spigelmyer's colleagues are Leandro Sergio,Brett Clemmer,Samyuktha BR
Lisa Spigelmyer's latest job experience is associate director global regulatory affairs at iqvia at IQVIA
Lisa Spigelmyer's latest education in Ursinus College
