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Online Resumes with "Regulatory submissions"
QA Manager, Boca raton, FL
To obtain a position where my education and experience and previous work history would help the firm. I am knowledgeable and have worked with 21 CFR 11, 210 and 211.I was responsible for all 3rd party audits; was the responsible head for all FDA audits and responses; headed the CAPA and OOS Investigations and was involved with International Regulatory submissions as well as all FDA submissions. I was resopnsible for all OO...
Tags for this Online Resume:
Quality Assurance, Quality Control, Manufacturing, Teaching, Bio-Statistics, Regulatory
Toxicologist with over 30 years experience in safety assessment, program management and regulatory submissions
Looking for a role in drug or medical device development in North America or Europe where I can use my technical, scientific, management and regulatory expertise.
Tags for this Online Resume:
Toxicology, Nonclinical, Preclinical, Safety assessment, Drug development, Program management, Regulatory submissions
Associate Director for CMC Support and Drug Development
Pharmaceutics development Scientist devoted to innovative targeted drug development to treat difficult to cure diseases such as HIV, HCV and cancer. Seeking solutions to integration of drug substance and drug product clinical development through cost effective research and process development to improve safety and quality of life to bring down growing healthcare costs
Tags for this Online Resume:
GMP Manufacturing, Prharmaceutics Formulation, CMC Submissions, Quality Control, Clinical Operation, Operations Management, Small Molecules and Biologics GMP Manufacturing, Prharmaceutics Formulations, CMC and Regulatory Submissions, Analytical Method Development and QC, Clinical Operation and Clinical Development, Research Operations Management
Featured Profile
Scientist
Scientist/Study Director in conducting safety assessment, regulatory submissions and marketing of pharmaceuticals and medical devices in pharmaceutical company with world wide marketing.
Tags for this Online Resume:
everett, general toxicologist, leadership, data analysis, seattle, study director, nonclinical studies, Sacramento, San Francisco, safety assessment
Scientist- 14 years-Chicago
I am a R&D Pharmaceutical Microbiology scientist, supporting new products development and marketed products, developing and validating microbiology methods, FDA and global regulatory submissions, gap assessments and remediation, VPP site R&D safety Chair, Write Lab investigation and CAPA.
Featured Profile
Innovation and ideation by bridging the gap between business and science
I aim to bring innovative technologies and processes to the customer by directly investigating customer unmet needs and coming up with solutions that are truly different; not just incremental changes, but new products and processes that the customer doesn't even know they need right now.
Ideal Companies: Ideo, Google, Genentech, Agilent, Any medical device or biotechnology startup, Venture Capital, Healthcare Innovation Lab, Subaru, General Motors, Nissan, TE Connectivity, Elekta, Johnson & Johnson, GE Healthcare, Frog Design, Nike, Apple
Tags for this Online Resume:
Innovation, Ideation, Concept, FDA, PM, Customer interviews, Market research, Project Management, Ethnographic Research, Brainstorming, Financial modeling, Technology assessment, Start-up, Strategy, Business Development
Coordinator, Los Angeles
Over 14 years of clinical research experience and over 22 years of medical clinical experience working in a world renowned healthcare organization, private practices, and private research groups. Conducted pharmaceutical Clinical Trials phase II, III and IV. Ability to work under pressure and meet deadlines; work independently and self‐directed; pay attention to detail, identify and resolve problems; work as a member of a m...
Tags for this Online Resume:
COORDINATOR , ASSOCIATE
Director,/VP. A Pharmaceutical mfg. company anywhere in west coast.
Manage a team of scientist and professionals in R & D of a Pharmaceutical Company. Manage manufacturing operation of a pharmaceutical company. File necessary documents with regulatory agencies and seek approval of new candiddate pgarmaceutical products.
Tags for this Online Resume:
Pharmaceuticals R & D, Project Management , Pharmacurtical Manufacturing, Regulatory Submissions for Pharmaceutical Candidate Products, Troble Shooting during manufacture of Pharmaceutical products
Clinical Regulatory Submission Specialist/Publisher - 6 years Experience with MNCs
Seeking a challenging position in the pharmaceutical/biopharmaceutical industry that will allow me to utilize my six years of clinical research and regulatory affairs expertise, while being a key contributor to the healthcare community.
Regulatory Submissions - Document Management
Accomplished Pharmaceutical Professional with 10+ years of experience in regulatory submissions, document management, and project management positions. Record of success in developing and maintaining business solutions that guarantee compliance with international regulatory guidance. Recognized for ability to identify, learn, and effectively utilize emerging technologies to provide innovative business solutions. Exceptional...
Tags for this Online Resume:
Regulatory, Submissions, Document, Documentum, Acrobat
Scientist
Scientist/Study Director in conducting safety assessment, regulatory submissions and marketing of pharmaceuticals and medical devices in pharmaceutical company with world wide marketing.
Tags for this Online Resume:
everett, general toxicologist, leadership, data analysis, seattle, study director, nonclinical studies, Sacramento, San Francisco, safety assessment
Scientist- 14 years-Chicago
I am a R&D Pharmaceutical Microbiology scientist, supporting new products development and marketed products, developing and validating microbiology methods, FDA and global regulatory submissions, gap assessments and remediation, VPP site R&D safety Chair, Write Lab investigation and CAPA.
Featured Profile
Innovation and ideation by bridging the gap between business and science
I aim to bring innovative technologies and processes to the customer by directly investigating customer unmet needs and coming up with solutions that are truly different; not just incremental changes, but new products and processes that the customer doesn't even know they need right now.
Ideal Companies: Ideo, Google, Genentech, Agilent, Any medical device or biotechnology startup, Venture Capital, Healthcare Innovation Lab, Subaru, General Motors, Nissan, TE Connectivity, Elekta, Johnson & Johnson, GE Healthcare, Frog Design, Nike, Apple
Tags for this Online Resume:
Innovation, Ideation, Concept, FDA, PM, Customer interviews, Market research, Project Management, Ethnographic Research, Brainstorming, Financial modeling, Technology assessment, Start-up, Strategy, Business Development
Coordinator, Los Angeles
Over 14 years of clinical research experience and over 22 years of medical clinical experience working in a world renowned healthcare organization, private practices, and private research groups. Conducted pharmaceutical Clinical Trials phase II, III and IV. Ability to work under pressure and meet deadlines; work independently and self‐directed; pay attention to detail, identify and resolve problems; work as a member of a m...
Tags for this Online Resume:
COORDINATOR , ASSOCIATE
Director,/VP. A Pharmaceutical mfg. company anywhere in west coast.
Manage a team of scientist and professionals in R & D of a Pharmaceutical Company. Manage manufacturing operation of a pharmaceutical company. File necessary documents with regulatory agencies and seek approval of new candiddate pgarmaceutical products.
Tags for this Online Resume:
Pharmaceuticals R & D, Project Management , Pharmacurtical Manufacturing, Regulatory Submissions for Pharmaceutical Candidate Products, Troble Shooting during manufacture of Pharmaceutical products
Clinical Regulatory Submission Specialist/Publisher - 6 years Experience with MNCs
Seeking a challenging position in the pharmaceutical/biopharmaceutical industry that will allow me to utilize my six years of clinical research and regulatory affairs expertise, while being a key contributor to the healthcare community.
Regulatory Submissions - Document Management
Accomplished Pharmaceutical Professional with 10+ years of experience in regulatory submissions, document management, and project management positions. Record of success in developing and maintaining business solutions that guarantee compliance with international regulatory guidance. Recognized for ability to identify, learn, and effectively utilize emerging technologies to provide innovative business solutions. Exceptional...
Tags for this Online Resume:
Regulatory, Submissions, Document, Documentum, Acrobat
Innovation and ideation by bridging the gap between business and science
I aim to bring innovative technologies and processes to the customer by directly investigating customer unmet needs and coming up with solutions that are truly different; not just incremental changes, but new products and processes that the customer doesn't even know they need right now.
Ideal Companies: Ideo, Google, Genentech, Agilent, Any medical device or biotechnology startup, Venture Capital, Healthcare Innovation Lab, Subaru, General Motors, Nissan, TE Connectivity, Elekta, Johnson & Johnson, GE Healthcare, Frog Design, Nike, Apple
Tags for this Online Resume: Innovation, Ideation, Concept, FDA, PM, Customer interviews, Market research, Project Management, Ethnographic Research, Brainstorming, Financial modeling, Technology assessment, Start-up, Strategy, Business Development
