Regulatory Affairs Specialist
2 semanas atrás
Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and requirements. Develop stakeholder tools, process/document regulatory risk assessments, and provide support, expertise and represent the unit with other functional units, sponsors, researchers and/or regulatory authorities. Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines. May be required to coach peers and/or provide input for staff performance reviews Unit Management Coordinate the day to day delivery of regulatory services and processes, including compilation of regulatory filings/submissions/revisions for projects, third party vendors and clinical sites. Conduct or assist with regulatory and/or safety reviews, create regulatory-related tools, educational/training materials, and remain current on all aspects of clinical research regulatory requirements and industry best practices, communicating changes to project leaders in a timely manner. Client Services As the corporate subject specialist in regulatory affairs, provide regulatory, ethics and/or pharmacovigilance guidance and support to project stakeholders. Represent the unit at project meetings, assisting with project education/regulatory tool development, at regulatory reviews and audits, with clients ensuring expectations are managed and met, with regulatory, ethics and government representatives and, when appropriate, respond to regulatory queries on behalf of the client. Regulatory Strategy Development Identify changes in clinical research regulatory requirements and industry best practices and recommend, implement, and maintain corporate regulatory strategies, working with other experts (safety, quality assurance) when appropriate, to meet or exceed compliance requirements of evolving regulatory initiatives. Participate in specialized conferences/meetings to increase knowledge as needed. Project Support Regularly respond to registration requests and work with project teams to identify regulatory requirements. Assist in the preparation of regulatory submissions and support summaries. Ensure project/clinical site files and documents are developed, maintained, revised, archived and/or destroyed in accordance with project and regulatory requirements and that all project stakeholders are fully informed and trained on all applicable regulatory requirements. Qualifications Applicants should have a minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs. The successful candidate will possess strong knowledge of EMA regulations. Working Conditions Home-based *Accommodations for job applicants with disabilities are available upon request.
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Regulatory affairs specialist
2 semanas atrás
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),...
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Regulatory Affairs Specialist
2 semanas atrás
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),...
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Brasil Kaizen Gaming Tempo inteiro R$90.000 - R$120.000 por anoWe are Kaizen GamingKaizen Gaming, the team powering Betano, is one of the biggest GameTech companies in the world, operating in 19 markets. We always aim to leverage cutting-edge technology, providing the best experience to our millions of customers who trust us for their entertainment.We are a diverse team of more than 2.700 Kaizeners, from 40+...
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Senior Regulatory Documentation Specialist
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Brasil beBeeRegulatory Tempo inteiroJob Overview As a Senior Regulatory Specialist, you will be responsible for ensuring that all regulatory requirements are met and that documentation is compliant with applicable regulations. The successful candidate will have primary contact with investigative sites during site start-up activities and maintenance. Your responsibilities will include the...
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Case processing specialist consultant
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Brasil ClinChoice Tempo inteiroJob Description Job Title: Senior Executive / Specialist - Case Processing Employment Type: Contract Location: Brazil (Remote) About Clin Choice Clin Choice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory...
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Case Processing Specialist Consultant
1 semana atrás
Brasil ClinChoice Tempo inteiroJob Description Job Title: Senior Executive / Specialist - Case Processing Employment Type: Contract Location: Brazil (Remote) About ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs,...
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Senior Financial Transaction Specialist
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Brasil beBeeRegulatory Tempo inteiroJob Overview: We are seeking a highly skilled Financial Operations Manager to oversee daily financial operations, encompassing accounts payable/receivable, cash flow tracking, and virtual asset transactions. About the Role: This is a key leadership position that requires strong organizational and communication skills to collaborate with accounting firms...
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Senior Regulatory Specialist
4 semanas atrás
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...
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Senior Regulatory Specialist
4 semanas atrás
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...
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Senior Regulatory Specialist
4 semanas atrás
Brasil Fortrea Tempo inteiroPrimary 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 Readiness team...
