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Online Resumes with "FDA EMEA"
Skilled in FDA, EMEA, Japan and other International regulatory agencies. Excellent background in method development, training, validations of equipments and methods, IND filing. Experienced in developing and implementing regional and nationwide quality programs for GMP and GLP laboratories, standard operating procedure and quality systems.
Tags for this Online Resume: Quality Assurance
Accomplished Regulatory Analyst with expertise in all stages of drug lifecycle management and experience in strategy implementation and submission management, eager to contribute to the success of a progressive organization. Proven success in achieving and exceeding company goals and objectives in all aspects of day-to-day regulatory affairs and quality assurance initiatives. Adept at recognizing and analyzing several the...
Looking for Quality Assurance position in Medical Kit manufacturing and Pharmaceutical companies (ISO13485, MHRA,FDA and EMEA) experience to add value and enhance my technical and managerial experience.
Experienced Clinical Research Professional and Project Manager with over 6 years in managing clinical studies and over 12 years working within Clinical research in the Pharmaceutical industry. Proven ability to manage a clinical trial from start-up through clinical study report and FDA, EMEA approval. Brings strengths of communication, collaboration with other departments and promoting effective teamwork. Known for peer l...
To obtain a leadership position for regulatory affairs expertise in the pharmaceutical/biotech industry
Over 19 years of Regulatory / Clinical Quality Assurance & Compliance / Auditing experience. Maintain an excellent knowledge base of all applicable Guidelines, FDA Regulations as well as best practices. I have prior interaction with the FDA, and EMEA/MHRA authorities, leading to successful outcomes. I am considered to be a strategic leader and planner effective in a team environment and customer service focused, with exc...
Seek position in R&D as a analytical development team leader handling multiple projects, coordinate project activities with various departments (quality assurance, Reg. CMC, Clinical Manufacturing Unit, Drug supply management, technical operations and outside contract laboratories. Direct analytical method development and oversee analytical development for the formulation development at contract labs
I was an auditor of activities within clinical drug development at AstraZeneca , having 11 years experience of a wide variety of audits such as for-cause, pharmacovigilance, clinical site and systems audits. My major accomplishments include FDA, EMEA and MHRA inspections, and I have led external audits in a range of countries and cultures, for example in USA, Canada, India, and many countries in EU and Latin America. I h...
Current MPH Student in Epidemiology at Columbia University, PhD in Biological Sciences, experienced in Clinical Research Development & Management, Pharmacovigilance and Health Information Technology.
My goal is to leverage my strong scientific, medical, and clinical trial experience as the foundation for building a career in Pharmaceuticals and Biotech companies. The positions I am interested are Clinical Scientist, Drug Safety Scientist, PV scientist, Non-MD Study Clinician, Clinical Trial Manager and other opportunities in San Francisco bay area. I am open to both permanent and contract positions.
SUMMARY OF EXPERIENCES & SKILLS: * Nine years of experience in Biochemistry. Primary area of expertise is HIV/AIDS research. * Very good familiarity with and certification in Good Clinical Practice (GCP) Familiarity with US FDA and EMEA guidance on clinical research * Master's degree work on determination of Human Immunodeficiency Virus-1 serotypes * Other areas of expertise include molecular biology, immunology, organic ch...
SUMMARY * Certified Clinical SAS Programmer with years of experience in SAS Base/Advance with extensive knowledge in drug development process and clinical trials. * Extensively working on various therapeutic areas like Oncology, Dermatology, InfectiouDiseases, Respiratory, Copd, Immunology, Cardiovascular and Nuerology. * Extensively working on clinical trial projects (Phase I, II and III) with Bio-Statisticians, Data manag...