
Regulatory Affairs Specialist
Há 4 dias
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 E2E 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 (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 GxP
Compensation: $15/hour - $25/hr USD
-
Regulatory Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil EBANX Tempo inteiroBuild your future with Sovos. If you\'re seeking a career where innovation meets impact, you\'ve come to the right place. As a global leader, Sovos is transforming tax compliance from a business requirement to a force for growth while revolutionizing how businesses navigate the e... Regulatory Affairs Specialist We are seeking a Regulatory Affairs...
-
Governmental & Regulatory Affairs Specialist
3 semanas atrás
São Paulo, São Paulo, Brasil UBS Tempo inteiroGovernmental & Regulatory Affairs Specialist Join to apply for the Governmental & Regulatory Affairs Specialist role at UBS Governmental & Regulatory Affairs Specialist Join to apply for the Governmental & Regulatory Affairs Specialist role at UBS Job Reference # BRJob TypeFull TimeYour roleAre you curious, have attention to detail and the ability to...
-
Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Alimentiv Inc. Tempo inteiroResponsible 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,...
-
Senior Regulatory Affairs Specialist
3 semanas atrás
São Paulo, São Paulo, Brasil BOEING Tempo inteiroAt Boeing, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We're committed to fostering an environment for every teammate that's welcoming, respectful and inclusive, with great opportunity for...
-
Regulatory Affairs Senior Specialist
1 dia atrás
Sao Paulo, Brasil Johnson & Johnson Family of Companies Tempo inteiro**Regulatory Affairs Senior Specialist**: At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1...
-
São Paulo, Brasil UBS Tempo inteiroBrazil - Compliance - Group Functions **Job Reference #** - 321151BR **City** - Sao Paulo **Job Type** - Full Time **Your role** - Are you curious, have attention to detail and the ability to pick up a variety of new topics quickly? You like working in a dynamic team responsible for delivering on key regulatory focus topics? We are looking for a...
-
Regulatory Affairs Expert
2 semanas atrás
São Paulo, Brasil beBeeRegulatory Tempo inteiro**Senior Regulatory Specialist Job Description** We are seeking a highly skilled and experienced Senior Regulatory Specialist to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and guidelines. **Key Responsibilities:** Maintain awareness of regulatory legislation, guidance, and...
-
Regulatory Affairs Specialist
Há 3 dias
São Paulo, São Paulo, Brasil Smith+Nephew Tempo inteiro R$80.000 - R$120.000 por anoLife Unlimited.At Smith+Nephew, we design and manufacture technology that takes the limits off livingAbout The RoleImagine a role where you're not just part of the process, you redefine it. At the heart of our innovative medical devices' company, we're looking for a trailblazer to join our Regulatory Operations team in Brazil. This isn't your typical...
-
Regulatory Affairs Senior Specialist
3 semanas atrás
São Paulo, São Paulo, Brasil buscojobs Brasil Tempo inteiroQuality Assurance Regulatory Affairs ManagerJob Summary:Highridge Medical creates the world's most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. Working at Highridge Medical is not just work. Life at Highridge Medical is purpose driven. Every day, you have the privilege of using your talents to...
-
Regulatory Affairs Intern
Há 5 dias
São Paulo, Brasil Edwards Lifesciences Tempo inteiro**How you'll make an impact**:Support the Regulatory Affairs LATAM (Latin America) team by performing activities such as:- Preparation of documentation for regulatory submissions- Requesting legal documents- Processing Regulatory Affairs suppliers payments requests- Tracking timelines and document milestone achievements- Interacting with different...