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Online Resumes with "eCTD Submissions"
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
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
Scientist - 15 Years of Experience - Near 10954
SUMMARY: * A pharmaceutical scientist with more than 15 years of experience supporting product development activities in an FDA regulated environment. * Seeking a position where my knowledge and skills in Pharmaceutical Product Development and CMC documentation can be applied with a potential for professional growth. * Skilled in the application of various physico-chemical analytical techniques in raw material and finished ...
Tags for this Online Resume: Enterprise Requirements Planning, Information Requests, Oracle, Oracle ERP, DSC, Product Development, Research, SAP, Filing, regulatory
Associate Director Regulatory Affairs
I am seeking an opportunity to continue working in Regulatory Operations focusing primarily on eCTD submissions and document management of Regulatory, Clinical, and Quality compliance documents.
Tags for this Online Resume: Regulatory Affairs, Regulatory Operations, eCTD Submissions, Clinical Trial Master Files, Quality Assurance, Document Management
Scientist - 15 Years of Experience - Near 10954
SUMMARY: * A pharmaceutical scientist with more than 15 years of experience supporting product development activities in an FDA regulated environment. * Seeking a position where my knowledge and skills in Pharmaceutical Product Development and CMC documentation can be applied with a potential for professional growth. * Skilled in the application of various physico-chemical analytical techniques in raw material and finished ...
Tags for this Online Resume: Enterprise Requirements Planning, Information Requests, Oracle, Oracle ERP, DSC, Product Development, Research, SAP, C Programming Language, Filing
