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Regulatory Affairs Consultant must have an understanding of the organization's consulting models and methodologies, as well as good knowledge of what services PC provides. The Consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. This key role in the organization ensures the timely performance of wo
Posted 25 days ago
Deliver/Lead specific Systematic Literature Review project steps e.g. screening, extraction, protocol design, quantitative feasibility. Understands project specific requirements to customize deliverables per specifics and apply innovative evidence presentation strategies. Develops project deliverables as required in a typical Systematic Literature Review project e.g., sys
Posted 25 days ago
1. Should have experience in eCTD, NeeS and paper formats. 2. Working experience in all major emerging countries (EU, GCC, US, ASEAN etc.) 3. Compilation, publishing, and technical quality control of Regulatory submissions including technical troubleshooting to ensure issues with submissions are resolved and deadlines met. 4.Should have experience in handling submission g
Posted 25 days ago
Senior Regulatory Affairs Associate must understand the organization's consulting models and methodologies, as well having as good knowledge of what services PC provides. The Senior Regulatory Affairs Associate must have good technical skills and may be developing specialist knowledge of a particular subject and/ or market. This key role in the organization ensures the ti
Posted 25 days ago
Supervise a team of front line QC Scientists. Performs administrative duties, i.e. hiring, performance management and supporting your team's development goals Schedules and assures adherence to schedule for the performance of analytical testing for biochemical analysis, so that all testing to support the production and release of product lots is performed in compliance wi
Posted 23 days ago
Locations VA Richmond, United States of America, Richmond, Virginia Principal Associate Process Management | Retail Data Management Control Operations The Retail Data Management and Governance Team at Capital One is dedicated to identifying, managing, and effectively mitigating data risk for our customers and our associates. We are seeking a highly motivated, disciplined,
Posted 2 days ago
include Ensuring the regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally. Implementation of the regional strategies in support of the project globally. Lead regulatory interactions and the review processes in local region. Ensuring appropriate interaction with regional commercial teams in local re
Posted 25 days ago
PMDA MHLW NDA 1. NDA US EU PMDA PMDAPMDA NDA CTDNDA ODD 2. CRO 10 PMDA JNDACTD PMDA Microsoft Excel WordPower Point
Posted 25 days ago
What success looks like in this role Engage with C level executives at our most strategic customers Drive innovation and setup deal structures aligned to the specific deal with associated economics Align to and provide support to deal team to get deals closed Help create the customer's AI business strategy You guide customers as they re imagine and document their digital
Posted 22 days ago
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. SUMMARY The Quality Analyst has the primary function to ensure
Posted 26 days ago
Deliver/Lead specific Systematic Literature Review project steps e.g. screening, extraction, protocol design, quantitative feasibility. Understands project specific requirements to customize deliverables per specifics and apply innovative evidence presentation strategies. Develops project deliverables as required in a typical Systematic Literature Review project e.g., sys
Posted 25 days ago
We are looking for a Senior Regulator y Affairs Associate to join our growing team in Romania. This role can be either home or office based in Bucharest. As a Senior Regulatory Affairs Associate you will come with a few years of Regulatory Affairs experience gained in the industry. You will bring experience in Clinical Trail Applications (CTA) from various European locati
Posted 25 days ago
SHIFT Day (United States of America) Seeking Breakthrough Makers Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation. At CHOP, your experience is valued; your voice is heard; and your contributions make a
Posted 16 days ago
Compliance Specialists are vital members of Jeffersonrsquo;s dynamic and diverse enterprise compliance team. The Compliance Specialist utilizes their excellent communication, strong problem solving and decision making skills to drive key operational activities designed to ensure that members of the Thomas Jefferson University and Jefferson Health community understand and
Posted 2 days ago
SHIFT Day (United States of America) Seeking Breakthrough Makers Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation. At CHOP, your experience is valued; your voice is heard; and your contributions make a
Posted 24 days ago
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