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Online Resumes with "Regulatory Authority"



Chief Financial Officer

Areas of Expertise: Strategic Planning - Capital Formation - Employee Development - Project Management - M&As - P&L Management Financial Planning, Analysis, & Control (FP&A) - Contract Negotiations - Change Management -Treasury - Insurance SEC Public Reporting - SOX Compliance - Financial Turnaround - Cost Savings - BIG Four Accounting (KPMG) Select Career Highlights * As COO of Maverick Drilling and Exploration Ltd., desig...

Tags for this Online Resume: Business Plan, Accounting, Business Planning, Capital markets, Compliance, Management, Planning, Equity, Business Plan, Accounting, Business Planning, Capital markets, Compliance, Management, Planning, Equity

Featured Profile

Clinical Research - 15 Years of Experience - Near 90001

I am seeking a position in Clinical Trial Management or as a Project Manager per my previous US and international experience.

Ideal Companies: Pharmaceutical or Biotech

Tags for this Online Resume: Oncology, Orthopedics, Surgical, Clinical Research, Management, Medical, Medical Affairs, Diabetes, Cardiovascular, Women's Health, Clinical Trial Management, Regulatory, Medical Writing, Microsoft, CTMS

System Engineer - 19 Years of Experience - Near 77083

SUMMARY A fully experienced electronics engineer with years of experience in maintenance effectively necessary upgrades to the system an organized and systematized engineer have great ability to troubleshoot. Extensive background in ATM installation, programming, and repair and servicing variety ATM machines, Complete knowledge of the mechanism used in ATM machines, highly capable at examining, identifying, and fixing faile...

Tags for this Online Resume: Advertising, Electronics, Install, Pricing, Risk Analysis, Security, Support

Clinical Pharmacovigilance/Drug Safety

SUMMARY * Medical degree with over 25 year experience in clinical and drug safety surveillance setting within the pharmaceutical and Biopharmaceutical industry (Example: Amgen, Alza Corporation, Idec, Biogen Idec, Elan, Genentech, Roche, Sharing AG, Wyeth, Élan Pharmaceuticals, Actelion Pharmaceuticals) * Advance knowledge of US and international Safety regulations and Safety assessment of Marketed and Investigational drugs...

Tags for this Online Resume: Training, Data Entry, Coding, Policies and Procedures, Clinical Research, Data Management, Immunology, Management, Oncology, Query

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

Clinical Research - 10 Years of Experience - Near 18901

Summary: * Several years of clinical experience in the industry with excellent knowledge of drug development in different therapeutic areas including oncology, immunology, vaccines, metabolism and biosimilars. Solid clinical practice experience. * Many years of Drug Safety, pharmacovigilance, risk management and epidemiology experience * Experience interfacing with health authorities (worldwide), institutional review boards...

Tags for this Online Resume: Oncology, Protocol, Regulatory Affairs, Risk Assessment, Management, Risk Management, Risk Management Activities, Complaints, Documentation, Hematology, Medical Affairs, Clinical Development

Chief Financial Officer

SUMMARY OF QUALIFICATIONS MBA and CPA with over 20 years of progressively responsible management, financial, accounting, and compliance experience with a Big Five accounting firm, Fortune 100 company and privately held companies. Strong leadership and interpersonal skills. Able to communicate and work effectively with persons at all levels and with a wide range of interests, including board of directors, corporate managemen...

Tags for this Online Resume: Budgeting, Certified Public Accountant, Compliance, Data Security, Financial, Financial Reporting, Insurance, Internal audit, Management, Risk Management

Construction & Building Inspector - 20 Years of Experience - Near 34683

Profile * Excel throughout all aspects of construction project management including project planning, estimating, cost control, resource allocation, and client relations for engagements valued at up to $200M. * Skillfully devise project plans and schedules to optimize human, financial and physical resources, and ensure budget-compliant delivery of projects from initial launch through completion. * Proven performance in OBO ...

Tags for this Online Resume: Arbitration, Engineering, Gas Turbines, Management, Power Plants, Project Management, Project Manager, Value Engineering, Purchasing, Construction

Featured Profile

Environmental compliance and Management

Summary I am an Environmental Services professional with extensive leadership and organizational experience in developing new business, co-ordinating multiple simultaneous projects at a variety of industrial, medical, and municipal facili- ties, as well as interfacing with regulatory agencies. I am a proven leader, coach, and team builder who has created cost savings for clients, and profits for my company.

Ideal Companies: GSG, Huff and Huff, Microbac, Carnow, Conibear & Assoc., Ltd

Tags for this Online Resume: Consumer Products, EMT, Leadership, human resources, Environmental Compliance, Business Development, Management, Services, Project Management, Accounting, management, sales, operations, environmental Compliance

Program Manager - 20 Years of Experience

Summary * Experienced in the management of strategic aspects of significant large complex onshore & offshore oil and gas, refinery, LNG and chemical projects * Significant project contributions included: * Improvements to schedule and avoidance of non-billable cost overruns * Increased project value through management of authorized change orders and scope changes * HSE and costs savings through implementation of Safety In D...

Tags for this Online Resume: Management, Onshore, Project Management, Project Manager, Pvc, Fabricators, Refineries, Refinery, SAP MM module, Integrate

Quality Assurance Director - 11 Years of Experience - Near 07076

SUMMARY Detail oriented and results focused professional with experience working in a global pharmaceutical company, research and development with multiple manufacturing sites and regulatory authorities worldwide. Possess clinical education, drug development and strong analytical background and solid understanding of the ICH, FDA, EMA Regulatory Guidelines as well as other regulatory body's guidelines and CMC requirements t...

Tags for this Online Resume: Good Laboratory Practices, Microsoft, Microsoft PowerPoint, Microsoft Visio, Policies and Procedures, Protocol, Quality, Quality Assurance, Research, Research and Development