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Online Resumes with "Regulatory Filing"
Financial Analyst - 16 Years of Experience
My objective is to add value which will also make everyone around me, both up and down the chain better. My past experience in working for various industries and my many years of experience as an accounting/finance executive will enable me to be extremely productive within any company. I bring with me passion, commitment and a desire not just to do my best, but to exceed expectations. My knowledge of KPI’s, P&L reporti...
Ideal Companies: Home Depot, Delta Airlines, Southwest Airlines, Southern Company, AT&T, Bank of America, Wells Fargo, Verizon, Sprint, State Farm,
Tags for this Online Resume: FInancial Reporting, Budgets, Projections, Forecasts, Payroll, Sox Compliance, Cost Accounting, Telecommunications, Dashboarding, SQL Reports, Month End Closing, Regulatory Compliance, Project Accounting, GL Systems, Multi State Audits, Contract Management, RFP Management, Tax, COGNOS Reporting
Global Regulatory Affairs - 14 Years of Experience- New Delhi India 110021
Seeking assignments as a Global Regulatory Affairs Professional - NCEs, GENERICS- Pharma, Biotech products, Botanicals & Medical Devices in Global Regions and/or Quality & Compliance professional across the Pharma & Medical Devices Industry. Overall Profile * With overall 15+ years industrial experience, with 14+ years in the field of Global Regulatory Affairs, Compilation & Submissions of Technical Packages for IND/CTA, ND...
Ideal Companies: BBraun Medical Pvt Ltd, New Delhi, India, Glenmark Pharmaceuticals Ltd., Mumbai, India, Panacea Biotec Ltd., New Delhi, India
Tags for this Online Resume: Regulatory Affairs, Management, Medical Devices, Pharmaceutical Industry, IND/CTA, Formulations & APIs, Regulatory Audits & Compliances, NCEs/NMEs/Generics, CT, Regulatory Consultancy, Regulatory Due Diligence & Gap Assessment
Study Coordinator
Summary Study Coordinator with 6 years' experience specializing in technical support of animal studies requiring GLP compliant interpretations, analysis, documentation, and reporting of results per FDA regulations beginning with protocol development support and creation of shell reports resulting in a Final product ready for FDA Regulatory Filings. Areas of Expertise / Core Competencies * Highly dependable, focused and dete...
Tags for this Online Resume: Documentation, Good Laboratory Practices, Protocol, Analytical Skills, Biomedical Industry, Quality, Quality Assurance, Coordinator, Medical Devices, Regulatory
Clinical Quality Assurance
SUMMARY OF QUALIFICAITONS * Global and domestic cGxP operation, quality and packaging experience in medical/precision and diagnostic devices, pharmaceuticals and biomedical industries * Managed Chemistry and Manufacturing Controls: including API sourcing, vender/raw material qualification, formulation, product/process development, scale-up, clinical supplies, technology transfer and validation * Wrote and compiled CMC porti...
Tags for this Online Resume: Cancer, Consumer Products, Engineering, OTC, Process Engineering, Product Development, Risk Analysis, Commercial Production, Team Lead, API
Chief Financial Officer
Accomplishments * Initial Public Offering (IPO) of one company ($70M) and significant responsibility in the formation and launch of another public company ($3B) * Merger and Acquisition transactions, ranging in value from $1 million to $50 million, including transactions in Canada and the United Kingdom * Raised more than $2 billion through various debt instruments - ranging from straight term to zero-coupon convertible deb...
Tags for this Online Resume: Financial, Financial Reporting, Financial Services, Management, SEC, Securities and Exchange Commission (SEC), Services, Accounting, Audit, Forecast
Life Scientist - 8 Years of Experience - Near 27617
Summary Ph.D in Pharmaceutics with extensive experience in analytical method development, method transfer and validation for Small and Large molecular API, in a GMP environment. Specialized in mass spectrometry/LC-MS method development and troubleshooting. Good knowledge of the GMP, GLP, SOP practices, the USP, EP, NF, FDA and ICH guidelines. Proven problem solver, motivated team leader and excellent communicator Qualificat...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), ELISA, protein, Protocol, LC-MS, MASS, API, Process Improvement, Application Program Interface, FORMULATION, QC, ANALYTICAL, pharmaceutics
Industrial Engineer
Qualifications of a Senior Industrial Engineer/ Project Engineer Dynamic results-oriented Senior Industrial Engineer with experience in product launch, pharmaceutical regulations, project management and development and execution of projects. Decision maker capable of making analytical judgments to drive the attainment of growth objectives through leadership and solving problem skills. Highly motivated by challenges and dedi...
Tags for this Online Resume: Management, Documentation, Manufacturing, Business Plan, Compaq Alpha, Corrective Actions, English Language, Good Manufacturing Practices, HR, Human Resources
Clinical Regulatory Affairs - 20 Years of Experience - Near 53143
Summary 30 plus years in the Medical Device and Pharmaceutical industry. Extensive expertise in Supply Chain, Customs Compliance (import and export), Test methods and Process Validations, Technical product development and support, GTIN and UDID process for organizations that meet GS1 standards. Experience in Customs Compliance and Quality Systems Regulations as well as domestic and international standards. Core competencies...
Tags for this Online Resume: Customs Compliance, Scrum Master, Regulatory Affairs, Validation, HR, Quality, Compliance, Hepatitis, Planning, Quality Assurance, Project Manager, Medical devices
Clinical Regulatory Affairs - 5 Years of Experience
Profile Regulatory Affairs Specialist with more than five years of experience in the pharmaceutical and biotechnology industries, implementing global regulatory filing strategies. Education in biotechnical engineering with deep knowledge and practical skills in managing the submission process from start to end, monitoring and tracking information, communicating with colleagues, managers and subject experts for efficiency an...
Tags for this Online Resume: Manufacturing, Packaging, Pharmaceutical, Regulatory Affairs, Biotechnical, Filing, Management, Medical, Medical Devices, Microsoft Office
Auditor - 11 Years of Experience - Near 91307
SUMMARY OF QUALIFICATIONS Managing/assisting/training team with day to day functions. Conducted case investigations, and preparing regulatory filings. Cleared Alerts along with brief narrative write up for escalation or the reason for clearing the alert. ECOA baseline review of transaction compliance (Deep Dive), recommendations to level of accuracy to meet CFPB and Reg B violations. I am familiar with Home Mortgage Disclos...
Tags for this Online Resume: Aml (Macro Lang), EDD, Audit, Documentation, KYC, Management, Policies and Procedures, Quality, Compliance, Quality Control, CIP
Financial Analyst - 18 Years of Experience - Near 91724
SUMMARY Goal oriented individual contributor with extensive experience in accounts payable, accounts receivable, regulatory filings, customer service, and contract administration in public utility and Fortune 500 corporations. Possess solid communication, team building, and problem-solving skills, and can adapt quickly to changes in organizational structure.
Tags for this Online Resume: Pricing, ACH, Gas Plants, Accounting, Microsoft Excel, Distribution, Financial, Management, Microsoft, Power (Os Enhancemnt Tool, finance, accounting, excel, accountant
Project Managers - 17 Years of Experience - Near 76248
SUMMARY Senior System Performance Engineer with an extensive background in 4G LTE, 3G CDMA, and In-Building optimizations. Optimized the performance of LTE macro cellular networks. Project and Risk Manager of In-Building and macro network projects. Tuned and optimized In-Building repeaters, small cells, and DRAN type fed systems. Experience in: * Completed successfully the migration of over 400+ cell site upgrades to 4G * V...
Tags for this Online Resume: Alltel, Cellular, Management, Mergers, PeopleSoft, Project Management, Project Manager, Purchasing, Rf, Wireless Construction
