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Online Resumes with "Regulatory approval"
Director - 20 Years of Experience - Near 08520
ACCOMPLISHMENTS * Lead client teams and CDMOs in Product Risk Assessments, EHS Analyses, Regulatory Audits, FDA PAI readiness program, interfaced with US Environmental Protection Agencies for new and updated Air Emission and Wastes Water Effluence permits. Manage OSHA training and audit programs. Reduced product technical and compliance risks while saving safety-related operating cost by reducing planned budget by >10%. Ben...
Tags for this Online Resume: Engineering, Manufacturing, Compliance, ECMS, HVAC, Infrastructure, Material Handling, OSHA, Business Development, Management, director, consultant, regulatory compliance
Regulatory Affairs, Quality, and Clinical Evaluation Consultant to Medical Device Industry
PROFESSIONAL PROFILE: A focused, driven, and passionate regulatory affairs and quality/compliance/auditing consultant with hands-on experience in RA and Quality/Compliance/Auditing associated with activities which lead to, and maintain regulatory approval to ISO 13485, FDA 510 (k), EU CE Mark & other international market authorizations of medical device products and conformance/compliance of Quality Management Systems. Regu...
Tags for this Online Resume: Management, Regulatory Affairs, Assessments, Audit, Budgeting, ISO, Microsoft Office, Quality, Quality Assurance, Quality Management, oncology, protocol, 13485, FDA, 483, Warning Letter, Portuguese, Spanish, ANVISA, Lead Auditor, Quality Systems, Quality Audit, Medical Device
Executive Director - 6 Years of Experience - Near 10005
SUMMARY An exceptional team player that leads organizations to continuously improve operations via LSS, business process optimization, design of experiments, data mining, capital investments and network consolidation. Excellent business sense coupled with technical aptitude, focused and determined work ethic to help drive innovation, collaboration on business objectives and how to increase revenue as needed. Passionate abou...
Tags for this Online Resume: Manufacturing, Management, P&L, Supply Chain, Business Development, Data Warehouse, Forecasting, Budgeting, Data Mining, Green Belt, management
Executive Vice President - 20 Years of Experience - Near 77055
Proven record closing profitable deals for wind, solar, natural gas, infrastructure, generation, distribution and other energy projects throughout the Americas. Directed every phase of development from origination, regulatory approval and financing to completion of projects valued to $2B+ for Nexta-Capital, BMR Energy, Sonnedix, GDF Suez and NextEra Energy / FPL Group. Consistently surpassed demanding ROI objectives...
Tags for this Online Resume: Global Growth Strategies, Startups, P&L, Turnarounds, Project Management, Mergers, Project Finance, A&D, Capital Markets, Planning, Negotiations, Strategic Alliances, Government Affairs, Bids, Proposals
Sr Project Manager Healthcare Construction - 20 Years of Experience - Near 34997
To build highly functional and cost effective hospitals, healthcare and research facilities. To integrate advanced medical technologies. Engaged to provide Owner's, Architect's and Builder's with clear guidance on the means, methods and techniques required to successfully complete healthcare projects. Lend expert help reviewing designs, understanding functional requirements, interpreting healthcare codes, knowing medical eq...
Ideal Companies: Hospitals, Hospital Builders
Tags for this Online Resume: Infection control, Engineering, Diagnostic Imaging, Hospital Planning & Construction, Clinical Laboratory Planning & Construction, Research Laboratory Planning & Construction, Medical Equipment Planning & Installations, Construction Managemnet, Project Manager, Functional Programming, Capital Budgets, Scheduling & Timelines, Quality Assurance / Quality Control (QA/QC), Commissioning, Client Relations & Management, Leadership, Mentoring, Successful Outcome, Operating Rooms, Special Procedure Rooms, Therapy, Healthcare, Research Equipment
Senior Counsel-Corporate and Regulatory Compliance - 20 Years of Experience - Near 11023
As a highly qualified and experienced financial services regulatory attorney specializing in the insurance and reinsurance field, both life and property/casualty, and as a practice team leader in my two most recent law firms, I demonstrate exceptional knowledge of federal, state and international regulatory and compliance issues, transactional acumen, client and employer loyalty, reliability, power of endurance and leaders...
Ideal Companies: Allied World, Swiss Re, Hiscox, XLCatlin, Arch Insurance, Chubb, MetLife, Berkshire Hathaway, Markel, QBE Insurance
Tags for this Online Resume: Acquisitions, Licensing, Mergers, Mergers and Acquisitions, Futures, Securities, Equity, Compliance, Commodities, Management
Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA
Clinical Regulatory Affairs - 20 Years of Experience - Near 80023
SUMMARY OF PROFESSIONAL EXPERIENCE Regulatory, Quality, Clinical and Compliance Medical Executive with major milestones/achievements in the Life Science Industry. Over 30 years in Class III and Class II devices/allograft/biologics, inside/outside the United States (OUS) primarily in the fields of cardiology, cardiovascular, neurology, spine and orthopedics. Integral involvement with 80+ product categories. Personally prepar...
Tags for this Online Resume: Medical Device, Regulatory/Quality, Clinical, Audit, Distribution, Budgeting, Microsoft Windows CE, Advertising, Cardiovascular, Compliance, clinical, trial, protocol, ich, FIM, EFS, gcp
Project team leader committed to safety and excellence.
Team-oriented or independent individual willing to work internationally or domestically, where 30+ years of experience and knowledge can be utilized to achieve the completion of projects for customers in an on time and safety driven environment.
Ideal Companies: TOTAL, TechnipFMC, Petrobras, Novatek, Saudi Aramco, BP
Tags for this Online Resume: Project Manager, Fabrication, Engineering, Construction, Management, Planning, ABS, Accounting, Budgetary, Consultant, Site manager, NDT, Technical writting, Specifications
