Empregos atuais relacionados a Regulatory Affairs Specialist - Rondônia - Alimentiv

  • Regulatory Affairs Specialist

    2 semanas atrás

    Rondônia, Brasil Indero Tempo inteiro R$90.000 - R$120.000 por ano

    Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and/or part II following EU CTR and other applications created within or outside of the company to ensure documentation comply with applicable regulations and guidelines and contractual...

  • Regulatory Affairs Specialist

    Há 4 dias

    Rondônia, Brasil Alimentiv Tempo inteiro

    **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...

  • eCOA & RTSM Application Specialist (Romania)

    Há 13 horas

    Rondônia, Brasil Indero Tempo inteiro 30.000 - 60.000 por ano

    The eCOA and RTSM Application Specialist is responsible for supporting the design, deployment, configuration, and oversight of electronic Clinical Outcome Assessment (eCOA) solutions—including ePRO, eConsent, and other patient-centric electronic data capture tools— and of Randomization and Trial Supply Management (RTSM) across global clinical...

  • Ecoa & Rtsm Application Specialist (Romania)

    Há 15 horas

    Rondônia, Brasil Indero Tempo inteiro

    The eCOA and RTSM Application Specialist is responsible for supporting the design, deployment, configuration, and oversight of electronic Clinical Outcome Assessment (eCOA) solutions—including ePRO, eConsent, and other patient-centric electronic data capture tools— and of Randomization and Trial Supply Management (RTSM) across global clinical...

  • Associate Project Manager, Early Phase

    Há 15 horas

    Rondônia, Brasil Indero Tempo inteiro

    The Associate Project Manager, Early Phase and Translational Research (APM, EPTR) ensures the successful initiation, planning, execution, monitoring, controlling and closure of assigned Early Phase clinical research projects. In addition, the APM, EPTR is responsible for the operational management and oversight of the clinical investigative sites as well as...

  • Chargeback Manager

    Há 2 dias

    Rondônia, Brasil Patrianna Tempo inteiro

    **Key Responsibilities**: - **Chargeback Process Management**: - Oversee the entire chargeback lifecycle from dispute initiation to resolution. - Investigate chargeback claims by gathering and reviewing transaction data, customer communication, and supporting documentation. - Ensure accurate and timely submission of chargeback representments (responses) to...

Regulatory Affairs Specialist

4 semanas atrás

Rondônia, Brasil Alimentiv Tempo inteiro
**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**:
- 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.
**Working Conditions**:
- Home-based- Accommodations for job applicants with disabilities are available upon request.