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Online Resumes with "Regulatory Affair "
Market Research Analyst - 15 Years of Experience - Near 92679
Tags for this Online Resume: Documentation, Infrastructure, Product Development, Regulatory Affairs, Management, Pulmonary, Distribution, ISO, Medical, Medical Devices, clinical
Chemist - 20 Years of Experience - Near 84341
Areas of Expertise * Batch Record Review * Transfer of Analytical Data (TAP) * GMP & Regulatory Affairs * Remediation * Process Validation * Deviation Resolution * Lab Environmental * CAPA Investigation * Quality Compliance & Assurance * Product Quality Management * Manufacturing of Sterile and aseptic products * 21 CFR, EU Regulations, and ISO 13485 * Safety and Regulatory Compliance * HPLC for API and Finished Product usi...
Tags for this Online Resume: Manufacturing, Pharmaceutical, High Performance Liquid Chromatography (HPLC), Management, Pharmaceutical Industry, Research and Development, Regulatory Affairs, API, Application Program Interface
Pharmacist - 2 Years of Experience - Near 11934
Tags for this Online Resume: Healthcare, Pharmacy, Pharmacist, Pharmaceutical, Insurance, Product specialist, Medical, Regulatory affairs
Director - 10 Years of Experience - Near 85234
Tags for this Online Resume: Health Insurance Portability And Accountability Act, Management, Quality, Quality Assurance, Quality Management, Audit, ISO, Mba, Regulatory Affairs, Security
Medical Scientist - 20 Years of Experience - Near 26501
Seeking challenging position in either pharmaceutical or academic institution.
Tags for this Online Resume: oncology, clinical, phase, protocol, sas, trial, gcp, pharmaceutical, ich, Regulatory affairs
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
Quality Assurance Engineer - 25 years experience- Los Angeles area
Manage quality assurance operations for a dynamic company
Tags for this Online Resume: Quality Assurance, Quality Control, Validations, molecular diagnostics, Regulatory Affairs, GMP documentation, technical writing, microbiology, Audit, Compliance, Data Analysis, Data Queries, High Performance Liquid Chromatography (HPLC), Medical, Process Improvement, Quality, Management, Risk Analysis, Risk Management, Test, complaint trending and analysis, Failure Analysis
Biomedical Engineer - 4 Years of Experience - Near 22209
Biomedical Engineering that learns quickly and takes on challenges with the objective of making a significant impact. A dynamic collaborator who is highly motivated and a persistent worker that takes initiative to learn and produce results, while maintaining a great focus on detail. Resourceful, analytical, and persistent with strong communication skills. Additional experience in numerical modeling, software development, an...
Tags for this Online Resume: Process Improvement, Biomedical Industry, Manufacturing, Quality, Quality Control, Regulatory Affairs, Support, Test, Regulated Environment, Engineer
Market Research Analyst - 19 Years of Experience - Near 92679
Tags for this Online Resume: Documentation, Infrastructure, Product Development, Regulatory Affairs, Management, Pulmonary, Distribution, ISO, Medical, Medical Devices, clinical
Clinical Research - 5 Years of Experience - Near 19128
SUMMARY * Project coordination, document management and coordination experience in a clinical health environment in pharmaceutical industry. Worked for Spark Therapeutics, Baxter, Execupharm, United BioSource (an Express script company) and Liquent (a Parexel Company) * 3 + years of experience in Regulatory Affairs supporting the compilation of regulatory submission and assisting with the publication those submissions using...
Tags for this Online Resume: Documentation, Microsoft Excel, Microsoft Office, Microsoft Outlook, CVS, Distribution, Document Management, Documentum, Documentum (Wkflow Sw), Financial
Chemist - 20 Years of Experience - Near 02467
PROFESSIONAL SUMMARY * A proven leader with a track record of accomplishments with more than fifteen years pharmaceutical industry experience in leading analytical development activities for small molecule drug development * Hands-on experience in analytical project management in drug development and regulatory submissions hands- on experience in analytical method development/validation/transfer in GMP environments expertis...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Quantify, Analytical Chemistry, Chemistry, Research, Research and Development, Regulatory Affairs, Applications, CMOS, Development Activities
Clinical Quality Assurance - 20 Years of Experience - Near 46360
Managed Quality Control / Quality Assurance / Regulatory Affairs departments in different roles for different companies for manufacturing packaging and distribution of drugs and devices. Designed flow processes for improvement of quality of products and quality of documents using proper validation protocols and procedures. Built quality management systems three times upgrading: Customer complaints investigations document co...
Tags for this Online Resume: Quality Assurance, Test, HYGIENE, Management, Publications, Quality, Six Sigma Quality, Packaging, Corrective Actions, Instrument Calibration, protocol, pharmaceutical, preventive maintenance
