Senior Regulatory Operations Expert

2 semanas atrás

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$90.000 - R$120.000

Job Summary

The senior regulatory operations professional will oversee the preparation, compilation, and submission of regulatory documents for clinical trials. They will manage electronic document management systems to ensure compliance and accessibility of regulatory documents.

Key Responsibilities:

  • Oversight of the preparation, compilation, and submission of regulatory documents for clinical trials;
  • Management of electronic document management systems (eTMF, eCTD) to ensure compliance and accessibility of regulatory documents;
  • Provision of support and guidance on regulatory operations processes to internal stakeholders;
  • Collaboration with cross-functional teams to ensure timely completion of regulatory deliverables;
  • Maintenance of regulatory operations processes to improve efficiency and compliance.

Requirements:

  • Bachelor's degree in a scientific or related field; advanced degree preferred;
  • Strong knowledge with publishing systems: specially with DocuBridge, Adobe Acrobat, ISI ToolBox, Liquent InSight Publisher and InSight Validator, Veeva Vault and Lorenz Validator;
  • Minimum of 3 years of experience in regulatory operations within the pharmaceutical or biotech industry;
  • Proficiency in electronic document management systems (eTMF, eCTD) and regulatory submission software;
  • Understanding of regulatory requirements and guidelines for clinical trials;
  • Excellent organizational, communication, and problem-solving skills;
  • Availability to work office based 3 times a week.

What We Offer You:

We are committed to building a diverse culture that rewards high performance and nurtures talent. We offer competitive salary packages, annual bonuses, health-related benefits, and retirement plans.

Why Work with Us?

You'll be working in a dynamic and supportive environment with some of the brightest and friendliest people in the sector. You'll be helping shape an industry and contributing to the successful execution of clinical trials and the advancement of innovative treatments and therapies.

  • Senior Regulatory Operations Associate

    2 semanas atrás

    São Paulo, São Paulo, Brasil ICON Plc Tempo inteiro

    Senior Regulatory Operations Associate - Hybrid - Brazil and MexicoICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentAt ICON, it's our people that set...

  • Regulatory Compliance Expert

    2 semanas atrás

    São Paulo, São Paulo, Brasil beBeeExpert Tempo inteiro R$120.000 - R$175.000

    Job Title: Regulatory Compliance ExpertJob DescriptionThe Regulatory Compliance Expert will play a crucial role in ensuring adherence to local regulatory requirements for medicines and services.Key Responsibilities:Providing expert advice on local regulatory requirements, including assessing regulatory change control by identifying requirements and...

  • Senior Regulatory Operations Associate

    4 semanas atrás

    São Paulo, São Paulo, Brasil ICON Tempo inteiro

    Senior Regulatory Operations Associate - Remote - Brazil and Mexico ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. At ICON, it's our people that...

  • Senior Regulatory Operations Associate

    4 semanas atrás

    São Paulo, São Paulo, Brasil ICON plc Tempo inteiro

    Senior Regulatory Operations Associate - Remote - Brazil and Mexico ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development At ICON, it's our people that set...

  • Senior Regulatory Expert

    2 semanas atrás

    São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$90.000 - R$120.000

    About This RoleAs a seasoned Regulatory Specialist, you will lead client-facing initiatives to expand and refine our content offerings. You will serve as the Sovos Point of Contact for requirements, deadlines, and deliverables.This role involves working closely with Sales and Professional Services teams on documentation and pricing. You will also engage in...

  • Regulatory Operations Associate

    2 semanas atrás

    São Paulo, São Paulo, Brasil ICON plc Tempo inteiro US$104.000 - US$130.878 por ano

    Senior Regulatory Operations Associate - Hybrid - Brazil and MexicoICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentAt ICON, it's our people that set...

  • Regulatory Expert

    1 semana atrás

    São Paulo, São Paulo, Brasil beBeeCompliance Tempo inteiro R$55.000 - R$75.000

    Compliance ProfessionalWe are seeking a highly skilled Compliance Professional to join our team. The successful candidate will be responsible for supporting the development and implementation of compliance procedures in line with regulatory frameworks.Support the development and implementation of compliance procedures in line with regulatory...

  • Senior Compliance Officer

    2 semanas atrás

    São Paulo, São Paulo, Brasil beBeeCompliance Tempo inteiro US$120.000 - US$150.000

    Job Title: Senior Compliance Officer - Regulatory Expert About the RoleThis is a critical position within our organization responsible for ensuring adherence to Brazilian and international regulations. The Senior Compliance Officer will oversee compliance with applicable laws, regulations, and internal standards. This includes ensuring timely and accurate...

  • Senior Regulatory Reporting Analyst

    4 semanas atrás

    São Paulo, São Paulo, Brasil Adyen Tempo inteiro

    Join to apply for the Senior Regulatory Reporting Analyst role at Adyen Join to apply for the Senior Regulatory Reporting Analyst role at Adyen Get AI-powered advice on this job and more exclusive features. Adyen provides payments, data, and financial products in a single solution for customers like Meta, Uber, H&M, and Microsoft - making us the...

  • Senior Operations Expert in Quality Score Optimization

    2 semanas atrás

    São Paulo, São Paulo, Brasil beBeeRider Tempo inteiro R$80.000 - R$120.000

    Rider Quality Score Operations Senior ExpertThe ideal candidate for this role will be responsible for maintaining and optimizing our quality score system to ensure it is fair and effective in evaluating rider performance.