Kimberlee Wilson
Director, Head of Global Dossier PlanningRegulatory Operations & Interim Head of EU Regulatory Operations
- Role
- Director, Head of Global Dossier Planning at Daiichi Sankyo US
- Location
- Phoenixville, PA, US
- LinkedIn followers
- 500 followers
About Kimberlee Wilson
Experienced, accomplished Regulatory Submissions planner with considerable experience in the global planning, reporting and regulatory guidelines of the pharmaceutical industry, specializing in the Oncology Therapeutic Area and partnerships/collaborations. Certified Project Manager (CPM) and Agile Scrum Master Certified. Solid knowledge of the US, EU, and rest of world drug development and marketing approval filings including RTOR and Project Orbis. Highly organized, project focused, with a reputation for meeting critical project timelines. Passionate about new initiatives which increase efficiency and add value to the organization. Patient and stakeholder focused, detail oriented, self-motivated and a fast learner. Experienced with eCTD, EMA & FDA regulations, and strong knowledge in reporting/ planning tools. Most recently filed the first Project Orbis in 2019 to gain approval for Endometrial Carcinoma.
Experience
Director, Head of Global Dossier Planning
Aug 2024 — Present
Education
Arcadia University
Bachelor's, Psychology
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