
Regulatory Affairs Specialist
Há 23 horas
Regulatory Affairs Specialist - Detalhes da Vaga. ? A key responsibility of this role is to identify and recommend improvements to business processes, regulatory data, and data definitions for the RIM platform, while working in close collaboration with Global Regulatory Operations (GRO), Global Regulatory Affairs (GRA) and cross-functional stakeholders (e. ?G. ?, IT, Clinical, Nonclinical, Quality). ? Identify opportunities within the RIM platform, to enhance compliance, efficiency, and reporting. ? Responsible for supporting RIM Reporting and Analytics needs across Global Regulatory Affairs as needed. ?Responsibility:Support efforts to align business processes to a RIM enterprise data strategy. ?Contribute to implementation of E2E RIM which includes new system implementation, change requests, upgrades, integrations, data quality, metrics & reporting, etc. ?Ensure users requirements are adequately documented and serve as the basis for system continuous improvement, process engineering/mapping, and/or new system selection. ?Conduct training and support change management activities in RIM implementation and upgrades. ?Track alignment of business processes and models across all business functions supporting global Regulatory product registrations. ?Lead and/or support initiatives to integrate Regulatory information and records globally and for acquired assets and products. ?Monitor emerging structured data standards or health agency requirements, assess business impact and define roadmap for addressing them. ?Required Skills and Experience: 6+ years of experience in working in a biotechnology or pharmaceutical Regulatory Affairs Operations environmentExperience in systems management or implementation in the life sciences industry or regulated industry. ?Must have experience in Veeva Vault RIMOther system experience preferred and may include Calyx, Lorenz, Integras, SPORIFY, and other Veeva Vaults (PromoMat, eTMF, Quality)Microsoft Office and Adobe systems
- Knowledge of regulations, processes and industry standards and best practices that govern regulated systems, records retention and GxPCompensation: $15/hour - $25/hr USD. Requisitos para participar do processo. ? . O que oferecemos.
-
Regulatory Affairs Specialist
Há 4 dias
Belo Horizonte, Brasil Insight Global Tempo inteiroJob Description: The position will have primary responsibility in the Global Development Information Management team. A key responsibility of this role is to identify and recommend improvements to business processes, regulatory data, and data definitions for the RIM platform, while working in close collaboration with Global Regulatory Operations (GRO),...
-
Regulatory Affairs Specialist
Há 3 dias
Belo Horizonte, Brasil Insight Global Tempo inteiroJob Description:The position will have primary responsibility in the Global Development Information Management team. A key responsibility of this role is to identify and recommend improvements to business processes, regulatory data, and data definitions for the RIM platform, while working in close collaboration with Global Regulatory Operations (GRO), Global...
-
Regulatory Affairs Specialist
Há 5 dias
Belo Horizonte, Brasil Insight Global Tempo inteiroJob Description: The position will have primary responsibility in the Global Development Information Management team. A key responsibility of this role is to identify and recommend improvements to business processes, regulatory data, and data definitions for the RIM platform, while working in close collaboration with Global Regulatory Operations (GRO),...
-
Senior Regulatory Affairs Expert
3 semanas atrás
Belo Horizonte, Brasil beBeeRegulatory Tempo inteiroJob Description As a Regulatory Specialist, you will serve as the primary point of contact for investigative sites during site start-up activities and maintenance. Your responsibility will be to collect and organize data and information required by regulatory authorities, including the preparation of study documentation. Key Responsibilities: Maintain...
-
Senior Regulatory Affairs Expert
1 semana atrás
Belo Horizonte, Brasil Caderno Nacional Tempo inteiroSenior Regulatory Affairs Expert - Detalhes da Vaga. ? Your responsibility will be to collect and organize data and information required by regulatory authorities, including the preparation of study documentation. ? Key Responsibilities: Maintain awareness of current regulatory standards and legislation in assigned countries. ? Coordinate and collect data...
-
Regulatory Data Manager
Há 24 horas
Belo Horizonte, Brasil Bebeeregulatoryaffairs Tempo inteiroJob Description:The role of the Regulatory Affairs Specialist involves leading improvements to business processes, regulatory data and RIM platform for the Global Development Information Management team.In collaboration with GRO, GRA, IT, Clinical, Nonclinical, Quality and cross-functional stakeholders, identify opportunities within the RIM platform to...
-
Senior Regulatory Specialist
Há 4 dias
Belo Horizonte, Brasil Fortrea Tempo inteiroJob Overview:Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site...
-
Specialist Corporate Affairs
Há 4 dias
Belo Horizonte, Brasil BHP Tempo inteiro**About BHP**: At BHP we support our people to grow, learn, develop their skills and reach their potential. With a global portfolio of operations, we offer a diverse and inclusive environment with extraordinary career opportunities. Our strategy is to focus on creating a safe work environment where our employees feel strongly connected to our values and...
-
Senior Regulatory Licensing Specialist
Há 24 horas
Belo Horizonte, Brasil Bebeecompliance Tempo inteiroWe are seeking a seasoned professional to lead our regulatory licensing efforts in Brazil.As a Compliance & Banking Partnerships Manager/Director, you will be responsible for navigating the complex world of Brazilian regulations and building strong relationships with key stakeholders.This is an exciting opportunity to leverage your expertise in anti-money...
-
Senior Compliance Specialist
2 semanas atrás
Belo Horizonte, Brasil beBeeRegulatory Tempo inteiroJob Overview The Senior Regulatory Specialist will be the primary contact with investigative sites during site start-up activities and maintenance. This role is responsible for collecting required documents, ensuring EC/IRB/Third body/Regulatory Authority applications are made within agreed timelines, and that documentation meets applicable regulations and...