Lisa Spigelmyer
Director, Regulatory Affairs and Drug Development at IQVIA
- Role
- Director, Regulatory Affairs and Drug Development at IQVIA
- Location
- Lancaster, PA, US
- LinkedIn followers
- 500 followers
About Lisa Spigelmyer
Regulatory professional with over with over fifteen years of experience in Regulatory Affairs. Extensive experience in managing the development of new drug products through the pre-IND, IND, and NDA/BLA 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.
Experience
Director, Regulatory Affairs and Drug Development
Mar 2024 — Present
Education
Ursinus College
Bachelor of Science, Chemistry
2004 — 2008
Skills
- 21 Cfr Part 11
- Microsoft Office
- Microsoft Excel
- Powerpoint
- Fda
- Validation
- Uv/Vis
- Design Control
- Capa
- Pcr
- Laboratory
- Hplc
- Quality System
- V&V
- Quality Control
- Gmp
- Data Analysis
- Quality Assurance
- Chemistry
- Research
- Lifesciences
- Root Cause Analysis
- Sds-Page
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