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Online Resumes with "FDA"
Regulatory Affairs Assistant at Medical Device Company-1 year experience-Boston
*Developed Quality Assurance and Regulatory Affairs processes, and managed databases. *Familiarity with medical device regulations, standards: ISO 13485 and FDA guidances *Support the submittal of product regulatory filings and maintenance with focus on US 510(k), EU technical files. *Review design control documents including protocols and reports associated with design inputs and outputs. *Interested in international m...
Tags for this Online Resume: regulatory, quality, medical device, international regulatory, FDA, 510k
Packaging Professtional, New Jersey
Packaging Professional with extensive experience in a variety of plant environments and technologies. In depth knowledge in the areas of FDA, OSHA, DEA cGMP issues and compliance. Demonstrated ability to build an organization and motivate associates to their maximum potential. Outstanding relationship building expertise with clients and management at all levels. Adept at increasing line efficiencies while reducing waste...
Tags for this Online Resume: packaging, cGMP, FDA, OSHA, Quality, Manufacturing
R&D/Lab Technician - 1 year Experience - Springfield, MA - Hartford, CT
I am interested in a career as a Lab Technician, Pharmaceutical/Medical Sales Rep, or Research and Development and believe that I possess the skills and meet the requirements necessary to be a worthy candidate. With my involvement in the pharmaceutical industry and my background, I am searching for a full time opportunity in the related field. I am available immediately and urge you to consider me for a position as I cons...
"Top Notch Project Manager"
Highly skilled Senior Project Manager specializing in implementing software applications in FDA and quality controlled environments. Resilient mindset for establishing, restoring and preserving solid client relationships. Mastery of task prioritization, resource management and delivering life-saving products on time and on budget.
Tags for this Online Resume:
Six Sigma, Project Manager, Implementation, Quality Control, FDA, Program Manager
Senior Analytical Chemist- 11 years experience- Quality Control in FDA-regulated drug manufacturing
Tags for this Online Resume:
Quantitative Analysis, HPLC, FDA cGMP regulations, Quality Control Laboratory, chromatography, USP
Life Scientist
Tags for this Online Resume:
Project Management PMP, Pathologist, FDA, Quality Control, Biodefense, Medical Countermeasures MCM
Featured Profile
Project Manager Delivering Quality and Timely Results
An ambitious, dedicated and accountable project manager who aims at delivering quality and timely projects. Claudia has high-standards and required experience to ensure projects are executed within projected budgets by maintaining cost management systems, through effective organization and management of resources and by conducting continuous analysis of project progress. She is a team leader on all of the department’s cli...
Ideal Companies: Johnson & Johnson, Merck, Pfizer, Quintiles, Amgen, Parexel, Hospital Corporation of America, Memorial Healthcare System, Therapeutics MD, Pharma
Tags for this Online Resume:
Project Manager, EDC, CTMS, Financial Reports, Data Entry, Clinical Research
Featured Profile
Executive Director
To lead a small to medium size nonprofit into its next level of growth on a national and global scale and to provide a voice for disabled students in our schools, courts and in the halls of congress.
Ideal Companies: Council of State Governments Justice Center and School Discipline Initiative, Amnesty International, Robert Wood Johnson Foundation, Gates Foundation, Bazelon Center for Mental Health Law, , Youth Training Collaborative, Advocates for Children in NY, , Policy Research Associates, Justice Polity Institute, National Center for Mental Health And Juvenile Justice, , New York State Permanent Judicial Commission on Justice for Children, Education Justice NY Law Center
Tags for this Online Resume:
Executive Director, President, CEO, Nonprofit, Advocacy, Public Policy, Disability, Mental Health Criminal Justice, Mental Health Juvenile Justice, ADHD LD Juvenile Justice, mental health, nonprofit, substance abuse, non-profit
Pharmaceutical, Biotech GMP regulated industries, over 20 years experience
Continue my knowledge and experience in a GMP, FDA, industries.
Tags for this Online Resume:
FDA,, cGMP, Pharmaceutical, Biotech, Manufacturing, DEA
Pharmaceutical/Biotech Quality, Compliance Director
I am available immediately & looking for a new opportunity. I am passionate and dedicated to the continuous improvement philosophy. My qualifications: Senior level cross-functional team management experience in GMP pharmaceutical, & biotech industries; thorough knowledge of current FDA & EU regulations and guidelines; well-organized, excellent communication & interpersonal skills, analytical problem solver; CAPA solutions,...
Tags for this Online Resume:
Senior Executive, Pharmaceutical/Biotech, Quality, Compliance, FDA Regulations
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
Project Manager Delivering Quality and Timely Results
An ambitious, dedicated and accountable project manager who aims at delivering quality and timely projects. Claudia has high-standards and required experience to ensure projects are executed within projected budgets by maintaining cost management systems, through effective organization and management of resources and by conducting continuous analysis of project progress. She is a team leader on all of the department’s cli...
Ideal Companies: Johnson & Johnson, Merck, Pfizer, Quintiles, Amgen, Parexel, Hospital Corporation of America, Memorial Healthcare System, Therapeutics MD, Pharma
Tags for this Online Resume: Project Manager, EDC, CTMS, Financial Reports, Data Entry, Clinical Research
Executive Director
To lead a small to medium size nonprofit into its next level of growth on a national and global scale and to provide a voice for disabled students in our schools, courts and in the halls of congress.
Ideal Companies: Council of State Governments Justice Center and School Discipline Initiative, Amnesty International, Robert Wood Johnson Foundation, Gates Foundation, Bazelon Center for Mental Health Law, , Youth Training Collaborative, Advocates for Children in NY, , Policy Research Associates, Justice Polity Institute, National Center for Mental Health And Juvenile Justice, , New York State Permanent Judicial Commission on Justice for Children, Education Justice NY Law Center
Tags for this Online Resume: Executive Director, President, CEO, Nonprofit, Advocacy, Public Policy, Disability, Mental Health Criminal Justice, Mental Health Juvenile Justice, ADHD LD Juvenile Justice, mental health, nonprofit, substance abuse, non-profit
