Kristen Wheeler
Director Global Regulatory Affairs @Baxter International Inc.
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WORK HISTORY
Director Global Regulatory Affairs @Baxter International Inc.
Lead Global Regulatory individuals and teams in the development of global strategies and regulatory submissions in line with the business objectives. Provide strategic direction for new registrations and post-marketing submissions; including supplements/variations, renewals, tenders, and MOH queries. Accountable for developing and maintaining US regulatory applications: INDs, NDAs (505(b)(2)), ANDAs, complex CMC changes, combination products, orphan drugs, DMFs (Type II and annual reports, PADERS/PBERS, and supplemental applications. Lead and participate in FDA meetings and complex negotiations with MOH globally. Lead and support development of EU regulatory strategies and procedures including national, MRP, DCP, CP, and variations including worksharing. Support BD (business development) opportunities including due diligence and transfer or regulatory applications globally.
EDUCATION
Northwestern University - Kellogg School of Management
RAPS Executive Development Program
DePaul University
Master of Business Administration (MBA)
Northern Illinois University
Bachelor's degree, Biology (Major) Chemistry (Minor)
SKILLS
ABOUT KRISTEN WHEELER
Highly motivated global regulatory affairs professional with over 25 years of experience…
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