Danielle M.
Regulatory Affairs Director @L'Oréal
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WORK HISTORY
Regulatory Affairs Director @L'Oréal
EDUCATION
UMDNJ/Rutgers University
Ph.D, Biomedical Engineering
Immaculata University
B.A, Biology
ABOUT DANIELLE M.
Experienced Regulatory Affairs Director possessing a strong background in product development, clinical research, and regulatory analysis for the drug, device, and consumer and personal care marketsSpecialties: • Compliance with Regulatory Guidelines • ICH Guidelines and HIPPA rules• FDA Regulations (i.e. 21 CFR)• Device Regulations• Project Management• New Claims Substantiation• Clinical Study Reports & Publications• Design Controls • Concept Innovation & Product Development• Clinical Trial Design • Competitive Strategy and IP• Design History File Development and Maintenance • GCP (Good Clinical Practice)• Microsoft Office (Word, Power Point, Excel, Project)• Enterprise Application Software
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