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Online Resumes with "NDA"



Project Manager - Administrator

Achievement and results-oriented professional with more than 15 years and 9500 hours effectively managing variety of projects, experience instituting organizational strategies, and administrative measures for continuous improvement and effective operation. Poised self-starter with a good sense of humor. Meet project deliverables and deadlines. Respond rapidly and appropriately to changing circumstances. Remain focused o...

Ideal Companies: Government agencies, DoD contractors, public policy non-profit

Tags for this Online Resume: Project Management, Chief Administrator - Office Manager, Executive, Vice President Administration, Events and Projects Manager, MS Office Suite - Word, Excel, PowerPoint, Outlook, Project

Dedicated Paralegal w/JD Degree

paralegal with JD degree working in intellectual property and IT specialist

Ideal Companies: google

Passionate innovator seeks new challenges

Driven, proven innovator who works well with others, creates market-changing opportunities and leads the strategic direction of the company.

Ideal Companies: level3, symantec, mcafee

Tags for this Online Resume: innovator, leader, security, technologist, startup

Goal-oriented, meticulous, highly organized

not only exceptional technical competency but also superior analysis, problem-solving abilities, leadership, communication and team member experience.

Ideal Companies: Companies that have more than 50 employees and been in business for awhile.

Tags for this Online Resume: sales and marketing, customer service, regulatory affair, research and development, management, sales, development

Senior Regulatory Writer (17 years experience)

I am seeking to end my present consulting status and return to an in-house position where continuity of projects is more realized. I have over 15 years experience writing regulatory medical documents that comprise CFR21 356h NDA/BLAs and eCTDs deliverables to the FDA/EU/Canadian regulatory authorities. I have written approximately 85 CSRs and can confidently say that ~40 of these were NCEs, early phase I/II and some pha...

Tags for this Online Resume: Regulatory Medical Writer Manager level

HSE Coordinator

To have a new challenge by joining a company project team and get a position with career Advancement scopes.

Director of Development

Strong leader, Inspirational, Confidence builder, Developer, Alliance manager, Partnership, External Focus

Ideal Companies: Diversity friendly companies, Strong leadership companies, Com[anies that are transparent with their employess, Merit based promotion and compansations

Vice-President Regulatory Affairs

To oversee regulatory affairs, write and/or review all documentation required by regulatory authorities for the conduct of clinical trials and for NDA approvals. To provide regulatory guidance and stratagies.

Tags for this Online Resume: regulatory affairs, QA/QC, clinical, management

regulatory affairs associate/specialist

Seeking a position in Regulatory Affairs where my skills, work ethic and achievements will be utilized to the best and which will provide me opportunities for intellectual and professional growth

Tags for this Online Resume: NDA, BLA, 510(K), ANDA, SOPS, PROTOCOLS, IND, PMA, PDP, LABELING , MEDICAL DEVICES, DIAGNOSTICS, IVD, CE MARKING, ICH,GMP,GLP,CBE-30,CBE-0, IB, SPL

Dr. JI-CV

Principal or Sr. Scientist in Pharmaceutical Analytical R&D, or drug development

Ideal Companies: Pharmaceutical Company or Drug development and research

Consultant - Regulatory Affairs, NJ

Seeking Regulatory Affairs position where 20+ years of experience in pharmaceuticals Regulatory Affairs and R&D will add value.

Tags for this Online Resume: RAC Certification, Microbiology and fermentation, toxicity assays high-throughput screening, CMC, project and staff management, submissions, compliance, IND NDA submissions, Consultant, molecular microbiologist, toxicity assays , project management, submissions, compliance, IND/NDA/eCTD, regulatory, pharmaceuticals, regulatory scientist

Associate director - Director, API-Drug Substance Manufacturing, Process Development and CMC

Tags for this Online Resume: Drug Substance Manufacturing, CMC, API Manufacturing, Process Development, IND, NDA