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Online Resumes with "Regulatory Affairs Professional"



Regulatory Affairs Professional, Massachusetts

Get a Full-time Opportunity in Regulatory Affairs

Quality Assurance and Regulatory Affairs Professional - NJ

Domestic and international regulatory strategy to market (medical device, pharmaceutical, combination and consumer products). Implement quality management systems; prefer start-up or small company environment where there is a lot of building (not maintaining) to do.

Tags for this Online Resume: CAPA, FDA, change control, PMA, complaint, CE Mark

Regulatory affairs professional

Tags for this Online Resume: SOPs , Dossiers, COAs, e-submissions, NDA, INDA

Featured Profile

Regulatory Affairs Professional - 10 years experience

Featured Profile

PhD Research Scientist With 12+years of Experience in Biomedical Sciences

I am seeking opportunities to contribute as a scientist within preclinical drug development or drug discovery research for the bio-pharmaceutical industry to support the primary or secondary screening and characterization of the molecular mechanism of action of lead drug candidates enabling target validation. I specialize in the development of cell-based assays using genomic, proteomic and biochemical approaches implementin...

Ideal Companies: Biogen Idec, Joule Scientific, Novartis NIBR, Aveo Oncology, Agios, Pfizer, Millipore, Merck, EMD serono, Third rock ventures, Cambridge Scientific, Alkermes, Enlight Biosciences

Tags for this Online Resume: Lentiviral Retroviral shRNA RNA knockdown screens, Flow Cytometry, RTPCR, Immunopreciptations, Reporter assays, Cell based Assays, ELISA, Migration, Stable and Transient Transfections, Genomic and Proteomic Studies, Cloning, Transient siRNA knockdowns, Phenotyping Mammalian cell lines, Gene Overexpression, Subcloning to expression Vectors, Construct Stable Inducible Cell lines, Protein Kinase Assay, Pulse Chase Experiments, Transfection, Transduction, Transformation, Polyoma virus DNA tumor virus replication, Research Scientist, Cell Biology Protein Biochemistry Genetics Molecular Bioliogy Oncology Virology, FACS

Regulatory Affairs Specialist

I am Regulatory Affairs Professional with a MS in Medical Devices and Diagnostics Engineering (Regulatory Track) and an BSc. in Electrical Engineering looking to pursue a career in the Medical Devices and In-Vitro Diagnostics Industry.

Regulatory Affairs Professional

I'm a clinical regulatory affairs professional with experience in taking medical device products to market in different countries. My experience includes all phases, including study design, budgeting and timeline development, medical writing (e.g., clinical protocol, IND, IDE, etc), clinical study initiation and oversight, data management, premarket notifications (e.g., 510(k), BLA, etc), clinical study reports, and direct ...

Tags for this Online Resume: FDA, ISO, submissions, 510(k), BLA, regulatory strategy, medical writing, management, medical devices

Quality Coordinator - 20 Years of Experience - Near L5B4A1

A qualified experienced Regulatory Affairs professional with a rich career full of success in regulatory affairs, projects management, Good Manufacturing practice guidelines (GMP) and pharmaceutical sites auditing. Provide good direction and experienced to lead Product Regulation Managers and Associates to develop and implement the regulatory strategies and processes to assure timely global commercialization of products in ...

Regulatory Affairs - 15 Years of Experience - Near 94565

Regulatory Affairs professional seeking to change industries for petrochemical regulatory matters to biotech and medical device industry. Proven aptitude to in dealing with regulatory authorites with special expertise in the Asia Pacific region.

Worldwide Director of Regulatory Affairs

Strategic Regulatory Affairs Professional with diverse and progressive experience leading growing or established companies in the pharmaceutical, biotech and medical device industry providing global strategic regulatory direction for both new and existing products, as a primary contact facilitating preparation of international regulatory documents. Advances the development of knowledge, products, people, collaboration, c...

Tags for this Online Resume: Product Registration, CMC, International Submissions, Global regulatory, BLA, INDs, Orphan Drugs, Project Management, Bilingual, International regulations

Managing Director - 20 Years of Experience - Near 33983

Accomplished pharmaceutical and medical device regulatory affairs professional with a passion for implementing successful regulatory strategies to support organizational business development goals.

Tags for this Online Resume: Microsoft Project, Excel, Adobe Acrobat, Microsoft Word, eSubmissions, Power Point, Microsoft Visio, Publisher