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Online Resumes with "Global regulatory"
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
quality manager
I am seeking a technical/quality management position directing, implementing, and maintaining Quality Systems in alignment with industry standards and the business strategy, and the global regulatory expectations of the organization.
Tags for this Online Resume: quality, analytical, qc, cmc, laboratory, small molecule
Senior Vice President/ Executive with over 15 Years of Experience
Assist companies with implementing successful solutions within budget while leveraging a risk mitigation approach to improve the business posture and achieve their strategic vision.
Ideal Companies: Mid-size to large companies; Astra Zeneca, IBM, CSC, SAE, FED, SEC, Government, SAIC, Banking: PNC, Wilmington Trust, Citi, BofA, Chase, DuPont.
Tags for this Online Resume: Enterprise Risk Management, Global Risk Management, Risk and Control Assessment, RCSA, Quality Reviews, Vendor Management, Chief Information Officer, Chief Security Officer, Executive Vice President, Managing Director, Chief Operations Officer, Chief Technology Officer, Senior Vice President, Big Data Governance, Governance and Oversight, Regulatory Audit Engagement
Clinical Research - 2 Years of Experience - Near 77449
HIGHLIGHTS OF QUALIFICATIONS: * RN with close to 2-years experience in clinical trials monitoring * Knowledgeable of clinical trial procedures and approval processes. * In-depth knowledge of ICH GCP guidelines and FDA regulations * Conversant with Design and Review of case report forms (CRF) * Conversant with Site Monitoring visits (PSVs, SIVs, IMVs and COVs) to meet study expectations. * Clinical and post-marketing safety ...
Tags for this Online Resume: Direct Patient Care, DRESSING CHANGES, Medical, Patient Care, Suctioning, Surgical, Wound Care, Acquired Immune Deficiency Syndrome (AIDS), HIV, Monitoring
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 Regulatory Affairs
Summary of Qualifications: Dedicated Project Management, Regulatory Affairs, and Quality Assurance Professional with global experience working in a regulated environment. Proficient at interacting across numerous functional areas and with all levels of Management. Knowledgeable in global regulatory processes, strategies, and requirements. Capable of seeing multiple complex projects through to successful outcomes. Excellent ...
Tags for this Online Resume: Management, Project Management, Regulatory Affairs, Corrective Actions, Pharmaceutical, Audit, Quality Assurance, Illinois
Director
QUALIFICATIONS: Over twenty years drug development experience ranging from pre-clinical pharmacology / toxicology to managing and directing clinical and cross functional teams in the conduct and execution of global, clinical trials. Experience includes coordinating and planning for budgeting, resourcing, drug supply, site and sponsor audits, and global regulatory submissions. Management experience includes management of in-...
Tags for this Online Resume: Data Management, Management, Nephrology, Clinical Research, Clinical Study Reports, Drafting, Oncology, Project Management, Project Manager, Protocol
Business Analyst - 2 Years of Experience - Near 78751
Profile * Global trade analyst with three years' experience in Global Regulatory Compliance (GRC), business process analysis and improvement and requirement gathering and documentation, with strong interest in Consultancy * Versatile, reliable and efficient with strong knowledge of Enterprise Resource Planning (ERP) with proficiency in Microsoft Office, Visio, Visual basic and HTML * Robust communication and time management...
Tags for this Online Resume: SAP, Claim Processing, Enterprise Resource Planning, Planning, Business Intelligence, Compliance, Documentation, Enterprise Requirements Planning, Compliance, DevOps
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
Supply Chain Manager
Areas of Expertise ( International / Global Logistics ( Process Re-Engineering / SOX ( Financial / Budget Management ( Global Import / Export ( New Procedure Implementation ( Problem Identification / Solving ( Supply Chain Management ( Global Regulatory Compliance ( International Documentation ( Strategic Partnerships ( Best Practices / SOP Creation ( IT Acumen / Technical Knowledge ( Vendor Relations / Negotiations ( Team ...
Tags for this Online Resume: Distribution, Logistics, Purchasing, Compliance, ISO, Management, Manufacturing, Procurement, ISO 9001, Supply Chain, Import
Director of Human Resources - 10 Years of Experience - Inland Empire
A global HR professional who excels in guiding teams to respond to challenges and transform them into legacy builders. Some of the top companies I worked for include APBI, OAO, NASDAQ, American University, MMEC Electronics Inc., with operations throughout North and South America, Europe, and Asia. My secret to success is the Four-Step methodology I used: 1. I do a needs analysis of what the company wants. 2. I recommend str...
Tags for this Online Resume: US & Global HR Management, US & Global Payroll, Taxation, US & Global Benefits Administration, Compensation Restructure, Global Incentives & Rewards, Expatriate Administration, Employee Relations & Labor Laws, US & Global Regulatory Compliance, Policies & Procedures Design, Team Leadership Motivation, Staffing, Training & Development, Startup Operations & Global Expansion, Mergers & Acquisitions - Process Improvement, Budget & Cost Control, Project Management
Quality Assurance Director - 20 Years of Experience - Near 92131
Summary Extensive strategic management development, deployment and execution supporting C-level, SVP and Sr. Management leading regulatory action remediation projects, coaching sponsors, key stakeholders and teams through containment, control, and compliance driving sustainability goals for Life Science companies in Biotechnology, Pharmaceuticals, Medical Device and Combination Products, addressing process improvement initi...
Tags for this Online Resume: Director Quality Assurance, Director Regulatory Affairs, Senior Project Manager, Director PMO, ISO, Software, Software Development, Quality Compliance, Director QARA
