Kelly Kaleck-Schlinsog
Director - Regulatory Strategy and Compliance Consulting @ProPharma
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WORK HISTORY
Director - Regulatory Strategy and Compliance Consulting @ProPharma
Trevor, WI, US
ProPharma Group acquired OneSource Regulatory in January 2023. Current position is with OneSource/ProPharma Group. EXPERTISE: Regulatory Strategy and Leadership | Team Leadership & Management | Compliance | Risk Mitigation | Labeling Development | Agency Meetings & Interactions | IND, NDA, BLA Submissions | Risk/Benefit Assessments | Audits
EDUCATION
Purdue University
Master of Science (MS), Regulatory and Quality Compliance
Carthage College
Bachelor of Arts (B.A.), International Business/German
ABOUT KELLY KALECK-SCHLINSOG
Regulatory Affairs professional with over 25 years of US and International experience in development and marketed pharmaceuticals (small molecule/biologics) and medical devices. FDA and Health Canada Agency Meetings, FDA Advisory Committee Meetings, Regulatory Advisory Panels, regulatory strategies and collaborations with external pharmaceutical companies.
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