Senior Regulatory Specialist

hace 2 semanas


Buenos Aires, Argentina IQVIA Argentina A tiempo completo
Job Overview

The Senior Regulatory and Start Up Specialist will be responsible for performing tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines. This role may also include maintenance activities.

Key Responsibilities
  1. Under general supervision, serve as the Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables, and project timelines.
  2. Perform start up and site activation activities according to applicable regulations, SOPs, and work instructions. Distribute completed documents to sites and internal project team members.
  3. Prepare site regulatory documents, reviewing for completeness and accuracy.
  4. Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
  5. Review and provide feedback to management on site performance metrics.
  6. Review, establish, and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plans as needed.
  7. Inform team members of completion of regulatory and contractual documents for individual sites.
  8. Review, track, and follow up the progress, approval, and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
  9. Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
  10. Perform quality control of documents provided by sites.
  11. May have direct contact with sponsors on specific initiatives.
Requirements
  1. Bachelor's Degree in life sciences.
  2. +3 years of clinical research experience within the regulatory area in Argentina:
  • Local submissions
  • ICF customization (site and country level)
  • Presentations to ethics committees & ANMAT.

• Fluent English: written and oral communication skills

• Ability to work independently

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at #J-18808-Ljbffr


  • Regulatory Specialist

    hace 2 semanas


    Buenos Aires, Argentina IQVIA A tiempo completo

    Regulatory & Start Up SpecialistWe are seeking a highly skilled Regulatory & Start Up Specialist to join our cFSP team in a Home Based role.Key Responsibilities:Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project...


  • Buenos Aires, Argentina Medtronic A tiempo completo

    **Careers that Change Lives **In this exciting role as a Regulatory Affairs Specialist, you will lead and prepare Regulatory Affairs (RA) meetings (regulatory status) involving cross-functional business partners under your responsibility. To provide status on time about projects and all applicable regulatory activities assigned per Senior Supervisor or RA...

  • Regulatory Specialist

    hace 3 semanas


    Buenos Aires, Argentina IQVIA A tiempo completo

    Job OverviewJob Title: FSP - Sr. Regulatory and Start Up Specialist in ArgentinaJob Summary: We are seeking a highly skilled Regulatory Specialist to join our team at IQVIA. The successful candidate will be responsible for performing tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or...


  • Buenos Aires, Argentina Givaudan A tiempo completo

    {"h1": "Regulatory Specialist Role at Givaudan", "p": "At Givaudan, we are passionate about creating innovative food solutions that delight consumers. As a Regulatory Specialist, you will play a crucial role in ensuring our products meet the highest standards of quality and compliance.Your key responsibilities will include drafting and assembling product...

  • Regulatory Specialist

    hace 1 semana


    Buenos Aires, Argentina IQVIA A tiempo completo

    Job Overview The Regulatory & Start Up Specialist will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines. This role may also include maintenance activities. Key...


  • Buenos Aires, Argentina IQVIA A tiempo completo

    Job SummaryWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at IQVIA. As a key member of our cFSP team, you will be responsible for ensuring compliance with regulatory requirements and facilitating site activation activities.Key ResponsibilitiesAct as a Point of Contact (SPOC) for investigative sites, Site Activation Manager...

  • Senior Operations Analyst

    hace 3 semanas


    Buenos Aires, Argentina S&P Global A tiempo completo

    About the Role:We are seeking a highly skilled Senior Operations Analyst - Regulatory Reporting Specialist to join our Global Regulatory Reporting Solutions team. As a key member of our team, you will play a critical role in providing exceptional customer experience to a broad range of clients and ensuring the fast and effective management of client...


  • Buenos Aires, Argentina Argentina A tiempo completo

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Argentina. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements for clinical studies.Key ResponsibilitiesAssist project teams in navigating regulatory requirements for clinical studiesPerform compliance assessments...


  • Buenos Aires, Argentina Roche A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Roche. As a key member of our regulatory team, you will be responsible for leading regulatory strategies and ensuring compliance across four countries: Argentina, Uruguay, Bolivia, and Paraguay, with a primary focus on Argentina.Key Responsibilities:Regulatory...


  • Buenos Aires, Argentina S&P Global A tiempo completo

    About the Role:We are seeking a skilled Regulatory Reporting Specialist to join our Global Regulatory Reporting Solutions team. As a key member of our team, you will play a critical role in providing exceptional customer experience to a broad range of clients and ensuring the fast and effective management of client workflows.Responsibilities and...


  • Buenos Aires, Argentina IQVIA Argentina A tiempo completo

    Job OverviewThe Senior Regulatory and Start-Up Specialist will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines. This may also include maintenance activities.Key...


  • Buenos Aires, Argentina Aon A tiempo completo

    About the RoleWe are seeking a highly skilled Senior Legal Compliance Specialist to join our team at Aon. As a key member of our legal and compliance department, you will play a critical role in providing expert advice and support to our business units, ensuring compliance with regulatory requirements and best practices.Key ResponsibilitiesProvide legal...


  • Buenos Aires, Argentina Aon Hewitt A tiempo completo

    {"h3": "Unlock Your Potential at AonAon is a leading multinational company that values diversity and inclusion. We are seeking a talented Senior Legal Compliance Specialist to join our team in Buenos Aires.As a Senior Legal Compliance Specialist, you will provide support in legal and compliance consultancy services to our internal clients, including...


  • Buenos Aires, Argentina IQVIA A tiempo completo

    FSP - Sr. Regulatory and Start Up Specialist in ArgentinaJob OverviewThe Sr. Regulatory & Start Up Specialist will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary...


  • Buenos Aires, Argentina Bayer A tiempo completo

    About the RoleWe are seeking a highly skilled Crop Protection Regulatory Affairs Specialist to join our team at Bayer. As a key member of our Crop Science division, you will play a critical role in ensuring the regulatory compliance of our crop protection products in the ConoSur region.Key ResponsibilitiesDevelop and implement regulatory strategies for new...


  • Buenos Aires, Argentina Boston Scientific A tiempo completo

    About Boston ScientificWe are a global leader in medical science, committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and...


  • Buenos Aires, Argentina IQVIA A tiempo completo

    We are looking for a Regulatory & Start Up Specialist to join our cFSP team in a Home Based role! Location : Argentina & México What You´ll Do Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project...


  • Buenos Aires, Argentina IQVIA A tiempo completo

    Job OverviewThe Regulatory and Start Up Specialist will perform tasks at a country level associated with Site Activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.Key...


  • Buenos Aires, Argentina Novasyte A tiempo completo

    POSITION TITLE: Regulatory Affairs Specialist REPORTS TO: Manager, Regulatory Affairs or Designee BASIC FUNCTIONS: ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: - Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory information, guidance,...


  • Buenos Aires, Argentina F. Hoffmann-La Roche Gruppe A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at F. Hoffmann-La Roche Gruppe. As a key member of our regulatory team, you will be responsible for leading regulatory strategies and ensuring compliance across multiple countries, with a primary focus on Argentina.Key ResponsibilitiesRegulatory Strategy &...