Regulatory affairs specialist
4 semanas atrás
Job 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 (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 E2 E RIM which includes new system implementation, change requests, upgrades, integrations, data quality, metrics & reporting, etc. Ensure user’s 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 environment Experience in systems management or implementation in the life sciences industry or regulated industry. Must have experience in Veeva Vault RIM Other system experience preferred and may include Calyx, Lorenz, Integras, SPORIFY, and other Veeva Vaults (Promo Mat, e TMF, Quality) Microsoft Office and Adobe systems • Knowledge of regulations, processes and industry standards and best practices that govern regulated systems, records retention and Gx P Compensation: $15/hour - $25/hr USD
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Regulatory Affairs Specialist
Há 7 dias
Brasil Alimentiv Tempo inteiro R$60.000 - R$120.000 por anoResponsible 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,...
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Regulatory Affairs Specialist
4 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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Pharmacovigilance specialist consultant
Há 2 dias
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 affairs,...
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Case processing specialist consultant
3 semanas atrás
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
3 semanas 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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Brasil Kuaishou Technology Tempo inteiroThis role is critical in managing escalations, mitigating risks, and protecting the integrity of our platform and community. Key ResponsibilitiesManage complex escalations from Customer Service and cross-functional teams, including copyright, advertising fraud, hate speech, minor safety, and underage accounts.Handle inquiries and escalations from...
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Clinical Site Manager
1 semana atrás
Brasil Planet Pharma Tempo inteiroClinical Site Manager – (Ophthalmology & Neurology Focus) Location: Remote-based We’re partnering with a global biopharmaceutical company dedicated to advancing treatments in Ophthalmology, Neurology , and other complex therapeutic areas. To support several ongoing and upcoming studies, we are seeking a Clinical Site Manager to oversee key investigator...
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Children's Clinical Site Manager
1 semana atrás
Brasil Planet Pharma Tempo inteiroClinical Site Manager – (Ophthalmology & Neurology Focus) Location: Remote-based We’re partnering with a global biopharmaceutical company dedicated to advancing treatments in Ophthalmology, Neurology , and other complex therapeutic areas. To support several ongoing and upcoming studies, we are seeking a Clinical Site Manager to oversee key investigator...
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Pharma validation engineer in ireland
Há 2 dias
Brasil PSC Biotech Corporation Tempo inteiroRole Description: Our site are excited to offer a fantastic Engineering Specialist (Validation) opportunity for candidates interested in a new challenge in a c GMP regulatory environment. The successful candidates will support several aspects of Validation. The roles available that will require experienced, energetic and committed engineers are in the...
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Quality Experience Specialist
Há 2 dias
Brasil Betfair Brasil Limitada Tempo inteiro R$60.000 - R$80.000 por anoQuality Experience Specialist Quality Experience Specialist Quality Experience Specialist We are looking for a Portuguese-speaking Quality Experience Specialist to join our BFI Quality Experience team in the Brazil office. Are you our next star player? As a Quality Experience Specialist, your primary focus is building a story which summarizes...
