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Online Resumes with "Global Regulatory Affairs"



Featured Profile

Senior Director, Chicago

To obtain a leadership position for regulatory affairs expertise in the pharmaceutical/biotech industry

Tags for this Online Resume: regulatory affairs, pharmaceutical, biotechnology, clinical , manufacturing

Director, Global Regulatory Affairs

Tags for this Online Resume: Global Regulatory Affairs, Cosmetics and OTCs, Consumer Products

Director Global Regulatory Affairs - 16 Years Experience

Energetic, results-oriented individual with established credibility and respect at FDA and EMA. An extraordinary record which includes the lead and approval on New Drug Applications (NDA) and Marketing Authorization Application (MAA)

Global Regulatory Affairs leader for a combination of RA functions. Provides clear and specific regulatory input using skills(scientist, regulator and lawyer) to provide strategic planning decisions and implementation enabling successful drug approvals. Strong leader, expertise in DD, alignment with business goals, creative, proficient with complex frameworks and integration of abstract concepts in clinical and CMC areas o...

Tags for this Online Resume: Regulatory Affairs, small molecules, CDER, CBER, FDA, EMEA, IND, NDA, CTA, IMPD, proteins, anti-infectives, cardiovascular, pain, oncology, CMC, compliance, communicator, monoclonal antibodies , Biologics, Food and Drug, Global, eCTD, health authorities, alliance management, combination products, Biologics Biosimilars , Director , pharmaceutical , Leadership, Problem solving , Innovation, experienced, IND NDA CTA MAA, business goals , biologics - pharmaceutical , biosimilars

EVP Operations, Global Regulatory Affairs, Environmental Compliance

I'm a senior level professional with a broad background in manufacturing with expertise in operaions management, environmental engineering and regulatory affairs.

Compliance Manager - 4 Years of Experience - Near 08827

Qualification Summary-Operations Manager Global Regulatory Affairs and Operations: I possess a unique combination of well-developed marketing, sales, and training management skills with 4 plus years’ experience performing regulatory and operations management activities supervising all International Documentation and labeling statutory and regulatory requirements for the exportation of all Johnson & Johnson Consumer, Inc. c...

Tags for this Online Resume: FDA, Operations Manager, Regulatory Affairs, Telecommute, Export, Global, New Jersey

Featured Profile

Research

To obtain a challenging position within the Pharmaceutical industry or medical devices industry that will allow me to use my experience to play a key role in Clinical Research studies and projects, and/or product development with medical devices.

Tags for this Online Resume: Clinical Pathology, laboratory method development, IQ, OQ, PQ, instrumentation, validation of medical devices, Regulatory, GLP, GCP, IRB, TMF, Project Manager, Documentation Specialist, Scientist, Archives

Featured Profile

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 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

Tags for this Online Resume: ISO, Compliance, Medical, Medical Devices, Good Manufacturing Practices, Health Insurance Portability And Accountability Act, Licensing, Management, Manufacturing, Microbiology

Human Resources Administrator

Tags for this Online Resume: Documentation, Logistics, Management, Quality, Quality Assurance, Quality Management, Troubleshooting, Drafting, Accruals, Billing