Lorraine A. Torres Montero | Senior Regulatory Compliance
20 + years in the Pharmaceutical Professional, Tri-Athlete and mom. Proven experience managing Regulatory and Quality aspects of the manufacturing operations in small molecule and biological drug substances and drug products. Able to develop insightful regulatory strategies for managing CMC changes, strong negotiator and problem solver. Adept at multitasking to achieve individual and team goals. Bilingual, Lorraine can deliver Regulatory and Biotechnology training in both English and Spanish. Lorraine enjoys outdoor sports, fine dining and travel.
Expertise:
Expertise:
- CMC Regulations and Submission Strategy Development
- CMC NDA and BLA Supplements, Global Variations
- Product Transfers and Licensed Applications
- CMC NDA and BLA Supplements, Global Variations
- GMP Regulations
- Global Regulatory Agencies Inspections
- Regulatory Compliance
- Field Alerts and BPDRs Submissions
- Drug Master Files, Site Master Files
- Training and Mentoring
New Stone Soup VT LLC is looking for associates to team with. Please send a letter of intent that includes a short bio/interest statement and one page white paper of your capabilities and services to Rita Vazquez-Torres | Founder/CEO.