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Online Resumes with "CTD"
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...
I strive hard to be the best SAS Programmer in the industry using my advanced skill set in SAS and applying my experiences.
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
Strong leader, Inspirational, Confidence builder, Developer, Alliance manager, Partnership, External Focus
To obtain a leadership position for regulatory affairs expertise in the pharmaceutical/biotech industry
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
to contribute to the expansion of the company