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Online Resumes with "eCTD"



Regulatory Affairs Professional

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...

Senior Technical Editor, Electronic Document Coordinator/Specialist

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

Regulatory Affairs Associate

Fulltime opportunity in Regulatory Affairs Function

Tags for this Online Resume: Regulatory Submission, ECTD, PDF Editor, SPL, Regulatory Compliance, Regulatory Compliance/FDA/EMA (EU), Clinical Trials, NDA/ANDA/IND/CTA, Medical Devices

Regulatory Affairs- Manager

to contribute to the expansion of the company

Tags for this Online Resume: Regulatory affairs, Pharmacist, Pharmacovigilance, CTD & e-CTD, Clinical Studies, Bioequivalence

Featured Profile

Director Regulatory Operations, Princeton, NJ

I am a regulatory affairs operations and publishing professional who has over 16 years experience in the publishing and management of Regulatory submissions. Expertise in the eCTD submission format for IND,NDA and MAA.

Tags for this Online Resume: ectd, regulatory, submissions, publishing, electronic applications, validation

Senior Life Scientist - 16 years Experience - Biotechnology - Colorado

A committed and highly accomplished biotechnology expert with 16 years of research and development experience, leading and supervising teams and managing a wide range of drug development projects for small biotechnology companies. Possesses knowledge and experience of pulmonary, cardiovascular, gastro-intestinal, and other disease indications and models. Vital skills and hands-on experience include science writing excellenc...

Tags for this Online Resume: Research and development, Writer, Communications, Science, Drug development, Supervisory, Biotechnology, Pharmaceuticals, Reports, Research, Team Leader, Project Management, Animal Models, IND, eCTD, Strategy, Recruiting, Drug Efficacy, Team, Management, Pulmonary, Gastrointestinal

Featured Profile

Research

To obtain a challenging position within the Pharmaceutical industry or medical devices industry that will allow me to use my experience to play a key role in Clinical Research studies and projects, and/or product development with medical devices.

Tags for this Online Resume: Clinical Pathology, laboratory method development, IQ, OQ, PQ, instrumentation, validation of medical devices, Regulatory, GLP, GCP, IRB, TMF, Project Manager, Documentation Specialist, Scientist, Archives

Featured Profile

Global Regulatory Affairs - 14 Years of Experience- New Delhi India 110021

Seeking assignments as a Global Regulatory Affairs Professional - NCEs, GENERICS- Pharma, Biotech products, Botanicals & Medical Devices in Global Regions and/or Quality & Compliance professional across the Pharma & Medical Devices Industry. Overall Profile * With overall 15+ years industrial experience, with 14+ years in the field of Global Regulatory Affairs, Compilation & Submissions of Technical Packages for IND/CTA, ND...

Ideal Companies: BBraun Medical Pvt Ltd, New Delhi, India, Glenmark Pharmaceuticals Ltd., Mumbai, India, Panacea Biotec Ltd., New Delhi, India

Tags for this Online Resume: Regulatory Affairs, Management, Medical Devices, Pharmaceutical Industry, IND/CTA, Formulations & APIs, Regulatory Audits & Compliances, NCEs/NMEs/Generics, CT, Regulatory Consultancy, Regulatory Due Diligence & Gap Assessment

Quality Assurance Director - 4 Years of Experience - Near 08736

Accomplishments: * Led a group of 6 employees in a 24-person firm * Led a group of employees and consultants to file Icotinib IND to FDA for NSCLC * Directly handled post - IND interactions/questions with FDA * Lined up Accenture to handle eCTD publishing and submissions * Led a group to assemble and file Briefing Packages to UK, Canada, Australia and Singapore Regulatory Authorities set up and presented face-to-face meetin...

Tags for this Online Resume: Regulatory Affairs, Advertising, Business Plan, Filing, Assessments, Business Development, Chemistry, Consulting, Due Diligence, Integrate

Architect - 11 Years of Experience - Near 08817

PROFESSIONAL SUMMARY * Experienced Selenium Automation Testing. * Good experience in Web UI automation testing with Selenium Web Driver, Java, Junit, TestNG frame works. * Proven experience in using Java and CSharp for Automation * Experienced in setup Project Setup in Eclipse * Experienced in suggest and creating new Framework from scratch or can adopt existing frameworks as well. * Experienced in working on Data Driven fr...

Tags for this Online Resume: Documentum, Documentum (Wkflow Sw), Integrate, Test, Test Plan, Java Programming Language, Javascript, Selenium, Sharepoint Technologies, Test Script