Alisa Benson
Regulatory Affairs Manager at Curium Pharmaceuticals
- Role
- Regulatory Affairs Manager at Curium Pharma
- Location
- Hillsboro, MO, US
- LinkedIn followers
- 500 followers
About Alisa Benson
I am a 25+-year veteran in the pharmaceutical and OTC industries with a wide range of…
Experience
Regulatory Affairs Manager
Oct 2023 — Present · St. Louis, MI, US
Support primarily North America including:Development and maintenance of labeling material artwork for new products and existing products in the portfolioCoordinate with Manufacturing on implementation of new labeling revisionsPreparation, submission, publishing and management of advertising and promotional materialsLead representative in the MLR review team for promotional materialsRegulatory intelligenceManagement of certain software utilized by Regulatory AffairsUser fee managementCARES Act reportingEstablishment registration managementDrug listing management
Education
University of Missouri-Saint Louis
Bachelor of Science
Skills
- Medical Devices
- Capa
- Regulatory Requirements
- Protocol
- Pharmaceutical Industry
- Sop
- Fda
- Biotechnology
- Six Sigma
- Gxp
- Quality Auditing
- Chemistry
- Analytical Chemistry
- Quality System
- V&V
- Lean Manufacturing
- Pharmaceutics
- Training
- Clinical Development
- Drug Delivery
- Lims
- Drug Development
- Biopharmaceuticals
- Life Sciences
- Project Management
- R&D
- Pharmacovigilance
- Quality Control
- Glp
- Gmp
- Regulatory Affairs
- Lifesciences
- Quality Management
- Standard Operating Procedure (Sop)
- Clinical Trials
- 5s
- Manufacturing
- Cross-Functional Team Leadership
- Process Improvement
- Iso 13485
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