Local submission of CTA according to the EU directive until the end of the transition period in Belgium, France, Luxembourg and Monaco, then submission according to EU CTR Local submission of MAP and NIS Education Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree Preferred Language skills Must be fluent in French and Englishcommunicat

. Work Schedule and Additional Information Full time employment Work hours are 9 00 AM to 5 00 PM, Monday Friday, with 30 minute lunch. Work hours may vary based on operational needs. Telework You may have the opportunity to telework, part time after the successful completion of the required probationary period. In order to telework, you must have a securely configured hi

. Work Schedule and Additional Information Full time employment Work hours are 9 00 AM to 5 00 PM, Monday Friday, with 30 minute lunch. Work hours may vary based on operational needs. Telework You may have the opportunity to telework, part time after the successful completion of the required probationary period. In order to telework, you must have a securely configured hi

. Work Schedule and Additional Information Full time employment Work hours are 8 00 AM to 4 00 PM, Monday Friday, with 30 minute lunch. Work hours may be negotiable based on operational needs. Telework You may have the opportunity to telework, part time after the successful completion of the required probationary period. In order to telework, you must have a securely confi

. Work Schedule and Additional Information Full time employment Work hours are 8 00 AM to 4 00 PM, Monday Friday, with 30 minute lunch. Work hours may be negotiable based on operational needs. Telework You may have the opportunity to telework, part time after the successful completion of the required probationary period. In order to telework, you must have a securely confi

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

. Work Schedule and Additional Information Full time employment Work hours are 9 00 AM to 5 00 PM, Monday Friday, with a 30 minute lunch. Work hours may vary based on operational needs. Telework You may have the opportunity to telework, part time after the successful completion of the required probationary period. In order to telework, you must have a securely configured

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

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

Team Lead for 4 Category Analysts and External Partners Drive Alignment and Prioritization with Global and Regional Raw Material Directors and Leadership Team(s) Enhance short and long term team vision Support, Enable, and Parter with assigned Category Managers Operate with knowledge of purchasing policies, processes, and guidelines Develop solutions to complex and time s

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

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

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

Primary Office Location One North Shore Center. Pittsburgh, Pennsylvania. 15212. Join our team. Make a difference for us and for your future. Position Title Manager of Model Validation Business Unit Risk Management Reports to Director of Enterprise Risk Management Position Overview This position is primarily responsible for leading all aspects of a model risk management f

PMDA MHLW NDA 1. NDA US EU PMDA PMDAPMDA NDA CTDNDA ODD 2. CRO 10 PMDA JNDACTD PMDA Microsoft Excel WordPower Point