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프린트
전체 252건, 현재 페이지 8/26
GPKOL
R & D기획
중국
- R&D: Drug discovery, business development, external innovation
인허가 PM
요르단
1. Regulatory Affairs - Establishing the strategic direction and execution of regulatory strategies with MENA(Middle East and North Africa) - Collaborating with senior management to provide planning, development and implementation of appropriate regulatory strategies/processes to ensure ongoing compliance with regulatory requirements for the targeted markets - Providing regulatory expertise and ensures appropriate regulatory guidance and support is provieded to development teams across the region - Providing insights and continual research into future direction of corporate Regulatory Affairs and how to best prepare, trends, regulations and changes, enabling company to take a proactive approach and proactive planning to future business requirements. 2. Project Management for key strategic regulatory projects with cross functional teams
인허가
멕시코
NDAs and ANDAs for local and abroad manufactured drug products(including biotech), medical devices and herbal medicines, regulatory strategies, knowledge of Mexican Official Standards(labeling, stability, GMP, registration and variation requirement
미국
- R&D Planning : Drug discovery including Lead Id,lead optimization, PK/PD, toxicology, PCC nomination, Molecular modeling - Natural product : Application to botanical drug, supplement, food additive, regulation in US and EU, and clinical study
R & D기획 PM
- Scientific and technical papers writing, database search for clinical and marketing decisions, grant applications and fund-raising for development and launching of new pharma products(innovation) - Overseeing each project across the entire path of drug development : from product definition to pilot product and clinical trials selection. - Drug development portfolio perfomance and improvement : projects selection(preclinical and clinical level), product definition, market analysis. planning, regulatory and industrial property affairs, project execution, tracking and reporting.
임상 인허가
말레이시아
- Clinical Trial : Many aspects of drug development focus on satisfying focus on satisfying the regulatory requirements of drug licensing authorities. These generally constitute a number of tests designed to determine the major toxicities of novel compound prior to first use in humans. It is a legal requirement that an assessment of major organ toxicity be performed(effects on the heart, liver, lungs and kidney) as well as effects on other parts of body that might be affected by drug. - Regulatory Affairs : Managing international regulatory issues and developing new regulatory policies and training of employees planning of new strategies to get products approved by government and engaging in post-marketing surveillance of products. Monitoring and follow up with Regulatory authorities for approval regulatory issues at National & international Level.
인허가 임상
- Clinical Trials : First in Human studies, Phase 1,2,3 and 4 studies – clinical trial strategies - RA : Regulatory strategies and interactions with FDA(regulatory submissions)
PM 기술마케팅
캐나다
- Project Management: Globalization and market entry in Canada, specializing in helping pharmaceuticals, healthcare companies and start-ups. Facilitate joint ventures, partnerships, research regulations with Health Canada and local provinces, assess competitive landscape, perform trade interviews and recommend sustainable market entry mode. Planning and Execution of all phases of market entry in Canada. - Technical and Marketing strategic planning and global execution.
- R&D planning: Drug Discovery research in cardiovascular, metabolic disease, antiviral and inflammation/immunology areas
임상 인허가 PM
- Clinical Trial: Expertise in designing, planning, and executing domestic and international Phase I-III clinical trials. Prepare clinical development documents, including but not limited to, protocols, IBs, operational documents/SOPs, and development plans. - Regulatory Affairs:Provide regulatory strategy guidance; prepare regulatory meeting background packages, clinical modules for INDs, CTAs, NDAs, and MAAs. - Project Management: Global CRO selection and management; project management to cover overall pharmaceutical development
