Empregos atuais relacionados a Regulatory Affairs, Study Start Up Specialist - Rio de Janeiro - Mexico

  • Regulatory Affairs, Study Start Up Specialist

    1 semana atrás

    Rio de Janeiro, Rio de Janeiro, Brasil Mexico Tempo inteiro

    **ALL CV ´s MUST BE SUBMITTED IN ENGLISH IN ORDER TO BE CONSIDERED****Essential Functions**:- Assist/Advise project teams on all regulatory requirements for clinical studies- Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings- Review and adapt study specific...

  • Regulatory Affairs Professional

    Há 2 dias

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeRegulatoryAffairs Tempo inteiro R$90.000 - R$110.000

    Enhance public health through innovative solutions in a dynamic regulatory environment.Regulatory Affairs SpecialistThe Regulatory Market team is seeking a skilled Regulatory Affairs Specialist to support Latin America and Canada region. This role involves close collaboration with local teams to ensure product compliance across the region.Key...

  • Regulatory Affairs Specialist F/m 1

    Há 3 dias

    Rio de Janeiro, Brasil bioMérieux Tempo inteiro

    A family-owned company, bioMérieux has grown to become **a world leader in the field of in vitro diagnostics**. For almost 60 years and across the world, we have imagined and developed **innovative diagnostics solutions** to **improve public health**. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large...

  • Regulatory Affairs Specialist

    Há 3 dias

    Rio de Janeiro, Rio de Janeiro, Brasil Alimentiv Tempo inteiro

    Overview Regulatory Affairs Specialist (LATAM) 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...

  • Regulatory Affairs Governance Professional

    Há 3 dias

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeSpecialist Tempo inteiro R$90.000 - R$120.000

    Regulatory Affairs SpecialistThis role requires an individual with a deep understanding of regulatory frameworks and the ability to develop integrated policy and advocacy strategies to drive business objectives. As a Regulatory Affairs Specialist, you will be responsible for creating and executing plans to improve regulatory environments, engage with key...

  • Regulatory Affairs Specialist

    1 semana atrás

    Rio das Pedras, Brasil beBeeRegulatory Tempo inteiro R$42.000 - R$65.000

    Regulatory Affairs Specialist Job DescriptionWe are seeking a skilled Regulatory Affairs Specialist to join our team in Piracicaba, SP. As a trusted partner, we are committed to making food systems safer, healthier, and more sustainable.Responsibilities:Provide regulatory support to sales and technical teams to ensure compliance with regulations;Support the...

  • Regulatory Affairs Specialist

    Há 4 dias

    Rio de Janeiro, Brasil Shell Tempo inteiro

    **The Role**: **Company description** As a global energy company operating in a challenging world, we set high standards of performance and ethical behaviors. We are judged by how we act and how we live up to our core values of honesty, integrity, and respect for people. Our Business Principles are based on these. They promote trust, openness, teamwork, and...

  • Regulatory Affairs Specialist

    1 dia atrás

    Rio de Janeiro, Rio de Janeiro, Brasil Shell Tempo inteiro

    **The Role**:**Company description**As a global energy company operating in a challenging world, we set high standards of performance and ethical behaviors.We are judged by how we act and how we live up to our core values of honesty, integrity, and respect for people.Our Business Principles are based on these.They promote trust, openness, teamwork, and...

  • Senior Regulatory Affairs Coordinator

    Há 6 dias

    Rio de Janeiro, Rio de Janeiro, Brasil beBeeRegulatory Tempo inteiro R$100.000 - R$120.000

    Key Responsibilities:Maintain regulatory awareness, ensuring up-to-date knowledge of applicable laws and guidelines.Coordinate the collection and organization of data and information required by regulatory authorities, including the preparation of study documentation such as country application forms and cover letters.

  • Senior Regulatory Specialist

    Há 6 dias

    Rio de Janeiro, Rio de Janeiro, Brasil Fortrea Tempo inteiro

    Job 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...

Regulatory Affairs, Study Start Up Specialist

2 semanas atrás

Rio de Janeiro, Brasil Mexico Tempo inteiro

**ALL CV´s MUST BE SUBMITTED IN ENGLISH IN ORDER TO BE CONSIDERED**

**Essential Functions**:

- Assist/Advise project teams on all regulatory requirements for clinical studies
- Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings
- Review and adapt study specific documents according to each country and site requirements
- Perform IRB/EC (CA) and/ or other Regulatory Bodies submissions on behalf of sponsors and and/or sites as agreed with the Sponsor and in accordance with each country requirements
- Receive and process study documentation from sites, check content and quality as well as completeness
- Interact with site personnel, CPCs, CRAs and PMs, for document corrections, clarification, or resolution of any incomplete and/or incorrect documentation found during document content quality review
- Compile Regulatory documentation according to CTI SOPs, sponsor SOPs and applicable country requirements, perform a QC review of all documentation before submitting to the sites, IRB/EC/CA and/or other Regulatory Bodies according to the local requirements
- Assist with and adapt Informed Consent Form (ICF) according to IRB/IEC requests on country or site level
- Assist in preparation, quality check, and filing of site adapted ICF according to local requirements
- Prepare and QC Clinical Trial Application forms (e.g., CTA, XML) where applicable
- Interact with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with CTI or Sponsor SOPs
- Respond to Deficiency Letters from IRB/IEC/CA and/ or other Regulatory Bodies in liaison with sponsor and study PM or assist sites in their response to IRB according to country and site requirements
- Compiling and assessing completeness of the Regulatory-Package for drug release (Regulatory Document Study Start Up Checklist)
- Provide Project teams with accurate periodic status reports in accordance with CTI SOPs and attend internal and external project meetings as needed
- Perform review, reconciliation, close-out, and archiving activities of study or project documentation according to CTI SOPs or sponsor SOPs
- Assist with preparation for Sponsor or Agency audits and inspections
- Assist with QC and QA of various study related Regulatory documents and reports
- Oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope
- Attend internal and external study meetings and regulatory status reports for each site and country during study meetings
- Sites budgets and Sites contracts management, depending on Countries/Regions

**Required Education/Experience**:

- Associate or Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience
- At least of 3 years of relevant pharmaceutical, site, or CRO Regulatory experience
- Experience in Clinical Trials Submissions in several LATAM countries
- Strong working knowledge and understanding of FDA, Good Clinical Practice (GCP) / International Council for Harmonisation (ICH) regulations and guidelines.

**Competencies**:

- Ability to work well in a team environment
- Ongoing willingness to learn
- Detail oriented
- Excellent verbal and written communication skills
- Fluent in oral and written English is a must, good Spanish language skills are also needed
- Ability to develop, prioritize, organize, and manage multiple tasks
- Ability to provide superior level of customer service
- Proficient in use of computer and software systems
- Ability to maintain confidentiality

**Why CTI?**
- We support career progression - We have a structured mentoring program to provide the support you need to move forward
- We value education and training - We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
- We value our people - We have never had a layoff in our 20-year history, support a work-life balance, and have provided cash bonuses every year for the past decade
- Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry
- We think globally and act locally - We have a global philanthropic program supporting our team’s efforts to improve their local communities (click here to learn more about our “CTI Cares” program)
- We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate (a recent report found that the average turnover for CROs in the US was 30%)
- Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-chan