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Online Resumes with "clinical regulatory affairs"



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

Agricultural Technician

Trainee Executive Regulatory Affairs

Agricultural Technician

Mexico

Able to expedite the documents required by Latin America BoH. Knowledge of the different sections (CTD) that have direct impact on the product. Knowledge of Latin America regulations relative to pharmaceutical and nutritional products. Capable of preparing documents for registration, variations and product renewals.. Knowledge of Good Documentation Practices. Able to expedite legal documents that make up a dossier. Evaluati...

Featured Profile

Clinical Affairs Director - 15 years experience - San Diego

An experienced senior manager seeking a biotechnology leadership position in a pharmaceutical, medical device or in vitro diagnostics company that values innovative solutions for managing diseases that have unmet medical needs.

Ideal Companies: Pfizer, Novartis, Illumina, Hologic, Genoptics, Edwards Lifesciences, Metametrics, Roche, Genentech, Thermo-Fisher Scientific, Avanir, Celgene, Pharmaceuticals, Zogenics, Arena Pharmaceuticals, Ignyta, Endologix, ISIS Pharmaceuticals

Tags for this Online Resume: clinical, affairs, scientific, trials, innovative, management, summary, documents, submission, regulatory, 510(k), ISE, ISS, PK/PD, communicating, monitoring, tactical, strategic, literature, direct, vision, Lead, Director, documentation, resources, execution, consensus, effectiveness, safety, CRA, IVD, medical, device, pharmaceutical, presentation, manuscript, abstract, poster, programs, leadership, career, development, appraisals, optimize, goals, objectives, internal, external, research, investigator, stakeholders, customers, prioritize, product, support, milestones, Microsoft, Word, Excel, statistics, data, analysis, Powerpoint, publication, growth, deliverables, diagnostic, prognostic, treatment, competitive, proven, ability, capable, assess, strategy, feasibility, methodology, design, develop, produce, recommend, recommendation, therapeutic, supervision, review, performance, appraisal, application, indication, company, collaborate, expert, justification, senior, executive, assessment, experienced, marketing, pre-market, pre-IDE, protocol, communication, utility, pharmacology, service, deliver, delivery, drug, metabolism, absorption, excretion, train, training, mentor, mentoring, CRO, reimbursement, XLSTAT, Prism, relationship, contract, consult, consultant, ownership, responsibility, authority, delegate, trends, direction, in-vitro, commercialize, commercialization, approval, clearance, patient, oncology, cancer, metabolic, cardiovascular, kidney, disease, health, outcomes, safe, effective, toxicity, novel, unique, unmet, need, advisors, advisory, committee, IRB, ethical, justified, supportive, care, associate

Projector/Administrative Coordinator - Compliance, Policies, 4 years experience - Atlanta, GA

I am a project/administrative coordinator with 4 years experience in hospital administration and close to 15 years of overall Healthcare experience including document specialist and medical transcriptionist.

Tags for this Online Resume: Project Coordinator, Compliance, Regulatory, Administrative Coordinator, Poilicies & Procedures, Safety Coordinator, Insurance, Document Specialist

Regulatory Affairs or Industrial Hygiene

Looking for a job as a regulatory affairs manager or industrial hygienist.

Tags for this Online Resume: Writing, Translating reports, Putting together Powerpoint presentations, Working with Excel, Budgeting, Industrial Hygiene

Senior Clinical & Regulatory Dtr./VP with over 20 years experience in all phases of product development.

Over 20 years of experience working in industry in biopharmaceuticals, and Class II-III medical device development. Perform hands-on management of Clinical Operations, and Regulatory Affairs. Oversee cross-functional product development teams and implement systematic project management techniques for clinical trials to ensure alignment with overall product development timelines and market release. Instill continuous quali...

Tags for this Online Resume: clinical research, project management, regualtory, medical device, cllinical trials operations, clinical development, research, IDE, 510(k), CE, PMA, BLA, NDA

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

Manager, Regulatory Affairs