Winnie Chen
Quality and Regulatory Professional in Pharma and Medical Device industries
- Role
- Regulatory Technical Manager at Fresenius Kabi USA
- Location
- Redmond, WA, US
- LinkedIn followers
- 500 followers
About Winnie Chen
15+ years as research, quality and regulatory professional in pharmaceutical/medical…
Experience
Regulatory Technical Manager
Apr 2022 — Present · Lake Zurich, IL, US
Defined and implemented regulatory strategies for NDA, ANDA, IND and supplements-Directed project teams as necessary based on scientific data, and changes in global regulatory environments-Anticipated risks and prepared for proper mitigation strategies for complex submissions-Provided expertise in translating regulatory requirements into practical workable plans-Proficient in scientific knowledge communication and guiding drug product development based on regulatory requirements-Experienced in reviewing technical documents for cGMP and regulatory compliance-Skilled in preparing and filing complex and high quality submissions, including NDA, ANDA, IND, controlled correspondence, supplements and annual reports-Proficient in providing strategy for formulation strategy (sameness, Q1/Q2), manufacturing/stability (bracketing/matrixing) and bioequivalence-Well-versed in FDA, USP, ICH and EP guidance
Education
Purdue University
M.S
2000 — 2006
Purdue University
PhD
2003 — 2006
National Taiwan University
B. S
1996 — 2000
Skills
- Lean Six Sigma
- U.s. Food and Drug Administration (Fda)
- Validation
- Pharmaceutical Industry
- Fda
- Pharmaceutical Development
- Technology Transfer
- Gmp
- Characterization
- Formulation
- Quality Assurance
- Biopharmaceuticals
- Hplc
- Lyophilization Development
- Pharmaceutics
- Pharmaceutical Scale-Up
- Six Sigma
- Microbiology
- Formulation Development
- Lyophilization
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