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Online Resumes with "505 b 2 "



Quality Assurance Director - 4 Years of Experience - Near 08736

Accomplishments: * Led a group of 6 employees in a 24-person firm * Led a group of employees and consultants to file Icotinib IND to FDA for NSCLC * Directly handled post - IND interactions/questions with FDA * Lined up Accenture to handle eCTD publishing and submissions * Led a group to assemble and file Briefing Packages to UK, Canada, Australia and Singapore Regulatory Authorities set up and presented face-to-face meetin...

Tags for this Online Resume: Regulatory Affairs, Advertising, Business Plan, Filing, Assessments, Business Development, Chemistry, Consulting, Due Diligence, Integrate

Scientist - 15 Years of Experience - Near 30045

PROFESSIONAL SUMMARY * Result oriented, Creative, Passionate, highly focused, experienced Pharmaceutical R&D Scientific Lead with good ethics, possessing over 15 years of experience in Formulation design, Process Development, Optimization and Scale up of various Pharmaceutical Dosage Forms, Solid Orals (IR and ER Tablets and Capsules), Liquid Orals (Solutions, Syrups and IR / ER Oral suspensions), and Parenteral formulation...

Tags for this Online Resume: Product Development, Filing, Pharmaceuticals (Generics), Formulation Research, Management, Budgetary, Process development, Oral solid dosage forms, Manufacturing, ANDAs

Clinical Pharmacovigilance/Drug Safety - 20 Years of Experience - Near 95117

CAREER SUMMARY * Senior, seasoned pharmaceutical R&D professional with strong administrative, strategic & scientific planning, and coordination/execution skills, gained through 27 years of industrial experience in leading CMC technical development function (Pharmaceutics & Analytical), and leading global development & regulatory filings for NMEs (small molecule and biologics / mAb), and 505 (b) (2) products strong expertise...

Tags for this Online Resume: CMC, Product Development, Regulatory Affairs, Good Manufacturing Practices, Management, Project Management, Technical Lead, DP, Product Development, Supply Chain, Technical Operations

Chemist - 12 Years of Experience - Near 08854

Seeking a challenging position in Pharmaceutical Industry/Research Organization, preferably where I can apply my expertise and experience in Analytical Research and Development/Quality Control and product development. Key Competencies * Dynamic, organized and highly experienced professional in Analytical Research and Development * Developed methods for assays, impurities and dissolution for Immediate Release as well as Modi...

Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Pharmaceutical Industry, Test, Documentation, pharmaceutical, Chemist