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Online Resumes with "IND NDA submissions"
Consultant - Regulatory Affairs, NJ
Seeking Regulatory Affairs position where 20+ years of experience in pharmaceuticals Regulatory Affairs and R&D will add value.
Tags for this Online Resume: RAC Certification, Microbiology and fermentation, toxicity assays high-throughput screening, CMC, project and staff management, submissions, compliance, IND NDA submissions, Consultant, molecular microbiologist, toxicity assays , project management, submissions, compliance, IND/NDA/eCTD, regulatory, pharmaceuticals, regulatory scientist
Clinical Quality Assurance - 20 Years of Experience - Near 94403
QA/QC experience working with FDA ICH and Japanese regulations 21 CFR reviewing Writing editing submission documentation SOPs Protocols Reports. Product/Project analytical requirements evaluation budget in-house vs. out-source estimation. Upgrading of R&D laboratories to GLP/GMP level.
Ideal Companies: small start-up company
Tags for this Online Resume: methods transfer validation, phase I, II, III protocols and reports, GMP GLP, Laboratory management, hiring training budgeting, FDA ICH regulations, validation monitoring transfer, medical devices, Consulting, Document Review, Documentation, DSC, High Performance Liquid Chromatography (HPLC)
Biostatatician - 18 Years of Experience - Near 07059
Experienced with IND/NDA submissions, and knowledgeable in regulatory guidelines (ICH), 21 CFR Part11 and Good Clinical Practice (GCP). * Highly experienced in clinical protocol development, experimental design, sample-size and power calculation, randomization, and study analysis planning (SAP). * Proficient in SAS/Base, SAS/Stat, SAS/Graph, SAS/Macro and SAS/ODS. * Skillful in data validation data manipulation, graph, tabl...
Tags for this Online Resume: Health Care Industry, clinical, protocol, sas, pharmaceutical, sap, ich, gcp, trial, phase, oncology
Production Manager - 157Years of Experience - Near 08723
SUMMARY * B.S. Biochemistry + M.B.A. Pharmaceutical Management with over 17 years of pharmaceutical industry experience * 12 Years of Parenteral Manufacturing experience. Member of PDA. Attended Courses at University Tennessee * 13 years of production experience in an FDA regulated environment such as Biopharma, OTC, medical devices in clinical, commercial drugs, consumer products, and nutraceuticals. * 11 years of producti...
Tags for this Online Resume: Forecasting, Medical, Project Management, Project Manager, Scheduling, 5S, Engineering, Kaizen, Outsourcing, SAP, production, manufacturing, reliability, "project management", Clinical drug supply, Packaging and labeling, GMP andGCP, SOP, 21CFR11
