Regulatory and Start-Up Expert

hace 1 mes


Ciudad de México, Ciudad de México IQVIA A tiempo completo
Regulatory & Start Up Specialist

We are seeking a skilled Regulatory & Start Up Specialist to join our cFSP team in a Home Based role.

Location: Argentina & México

Job Summary:

We are looking for a detail-oriented and organized Regulatory & Start Up Specialist to perform site activation activities in accordance with local and international regulations, standard operating procedures, and project requirements.

Responsibilities:

  1. Act as Point of Contact (SPOC) for assigned studies, ensuring seamless communication with investigative sites, Site Activation Manager (SAM), and Project Management team.
  2. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), and quality of designated deliverables and project timelines.
  3. Perform start-up and site activation activities, distributing completed documents to sites and internal project team members.
  4. Prepare site regulatory documents, reviewing for completeness and accuracy.
  5. Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
  6. Review, track, and follow up on the progress, approval, and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
  7. Provide local expertise to SAMs and project team during initial and ongoing project timeline planning.
  8. Perform quality control of documents provided by sites.
  9. Maintain direct contact with sponsors on specific initiatives.

Requirements:

  • Health Sciences degree or related field.
  • +3 years of clinical research experience within regulatory area: local regulatory submissions, knowledge of ICF, presentations to ethics committee.
  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
  • Advanced command of English language.
  • Good organizational and time management skills.
  • Good communication and interpersonal skills.


  • Ciudad de México, Ciudad de México National Museum of Wildlife Art A tiempo completo

    OverviewWe are seeking a highly skilled Regulatory Submissions Manager to join our Study Start Up team in Mexico City. This is an exciting opportunity for individuals with experience in clinical trial management to grow their career and contribute to the success of Medpace.

  • Regulatory Affairs Expert

    hace 4 semanas


    Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Expert to join our team at Worldwide Clinical Trials.Job DescriptionIn this role, you will be responsible for planning, initiating and tracking documents required for regulatory submissions. You will also be involved in collecting essential documents, reviewing country/site/EC requirements, and...


  • Ciudad de México, Ciudad de México Icon A tiempo completo

    At Icon, we are seeking a highly skilled Study Start Up Associate II to join our team. This role is an exciting opportunity for individuals who are passionate about delivering high-quality results in a fast-paced environment.Job Summary:The Study Start Up Associate II will be responsible for collecting, preparing, reviewing, approving, processing, and...


  • Ciudad de México, Ciudad de México IQVIA A tiempo completo

    Regulatory & Start Up Specialist Role OverviewThis position is responsible for participating in end-to-end site management from feasibility to site closure, serving as a primary point of contact for investigative sites and study team members.Key ResponsibilitiesSupport site qualification, regulatory green light, and site maintenance/close-outs.Participate in...


  • Ciudad de México, Ciudad de México National Museum of Wildlife Art A tiempo completo

    Regulatory Submissions ManagerWe are seeking a highly skilled Regulatory Submissions Manager to join our Study Start Up team in Mexico City. This role plays a key part in the clinical trial management process at Medpace, where you will utilize your expertise to develop and grow your career.ResponsibilitiesManage and execute all aspects of global start-up...


  • Ciudad de México, Ciudad de México National Museum of Wildlife Art A tiempo completo

    About the RoleWe are seeking a highly skilled Clinical Trials Regulatory Manager to join our team in Mexico City. This is a full-time, office-based position that plays a key role in the clinical trial management process at Medpace.ResponsibilitiesEfficiently manage and successfully execute all aspects of global start-upPerform quality checks on submission...


  • Ciudad de México, Ciudad de México TC Energy A tiempo completo

    Job DescriptionWe are seeking a highly experienced Commercial Performance and Regulatory Expert to lead our team in Mexico. This role will be responsible for managing commercial relationships, providing strategic advice, and representing TC Energy before regulatory bodies.About the RoleThis is a leadership position that requires excellent leadership and...


  • Ciudad de México, Ciudad de México Avantor A tiempo completo

    About the OpportunityAvantor, a global leader in the life sciences industry, is seeking a Quality Expert with Regulatory Compliance expertise to join its team.The Role:This is an exciting opportunity for a seasoned Quality Expert to work closely with cross-functional teams to ensure compliance with regulatory requirements and industry standards. The...


  • Ciudad de México, Ciudad de México National Museum of Wildlife Art A tiempo completo

    We are seeking a highly skilled Regulatory Submissions Manager to join our Study Start-Up team in Mexico City. This role plays a key part in the clinical trial management process at Medpace. If you want a challenging career where you can utilize your expertise and develop your skills further, then this is the opportunity for you.ResponsibilitiesEfficiently...


  • Ciudad de México, Ciudad de México 3M A tiempo completo

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico City.OverviewAs a Regulatory Affairs Specialist, you will play a key role in coordinating regulatory strategy for the Consumer Health Group division. You will provide support and expertise as part of the Regulatory organization, using your knowledge of...


  • Ciudad de México, Ciudad de México IQVIA A tiempo completo

    We are looking for a highly skilled Regulatory and Compliance Specialist to join our team in a Home Based role. This role will focus on 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...


  • Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completo

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Professional to join our team at Worldwide Clinical Trials. In this role, you will be responsible for planning, initiating, and tracking documents required for regulatory submissions, as well as coordinating with local investigators and key site personnel.About the RoleThis is a full-time...


  • Ciudad de México, Ciudad de México Cisco A tiempo completo

    Unlock a rewarding career as a wireless regulatory expert at Cisco. Salary: $150,000 - $200,000 per annum, depending on experience.About the RoleThis challenging position requires a seasoned professional with extensive knowledge of international spectrum regulation and wireless standards. As a key member of our team, you will be responsible for developing...


  • Ciudad de México, Ciudad de México SAO Fortrea Brazil Limitada A tiempo completo

    As a leading global contract research organization with a focus on scientific rigor and extensive clinical development experience, SAO Fortrea Brazil Limitada provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across multiple therapeutic areas.The Global...


  • Ciudad de México, Ciudad de México ERM A tiempo completo

    Libryo, an ERM Group Company, is a pioneering compliance platform that empowers global organizations to navigate complex Environmental, Health and Safety regulations.The company's mission is to provide actionable insights and expert knowledge to help businesses thrive in a rapidly changing regulatory landscape.We are seeking an exceptional Director of...


  • Ciudad de México, Ciudad de México TSYS Servicos de Transacoes Eletronicas A tiempo completo

    TSYS Servicos de Transacoes Eletronicas, a leading global payments technology company, is seeking an experienced Regulatory Compliance Expert to join our team in Mexico.The ideal candidate will have a strong background in regulatory compliance and experience working with payment networks. They will be responsible for ensuring that our operations in Mexico...


  • Ciudad de México, Ciudad de México MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, MEX Labcorp Clinical Development, S. de R.L. de C.V. provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than...


  • Ciudad de México, Ciudad de México Healthcare Businesswomen's Association A tiempo completo

    Company OverviewThe Healthcare Businesswomen's Association is a leading organization in the healthcare industry, dedicated to empowering women to achieve their full potential.About the RoleWe are seeking an experienced Senior Clinical Trials Manager to join our team. This role will be responsible for contributing to the delivery of clinical trial...

  • Regulatory Affairs Expert

    hace 4 semanas


    Ciudad de México, Ciudad de México Gilead Sciences A tiempo completo

    About Gilead SciencesGilead Sciences is a leading biopharmaceutical company dedicated to creating innovative therapies that improve lives. With over 35 years of experience, we have developed treatments for HIV, viral hepatitis, COVID-19, and cancer.We are committed to delivering exceptional results while maintaining regulatory compliance and ensuring access...


  • Ciudad de México, Ciudad de México World Business Lenders, LLC A tiempo completo

    About World Business Lenders, LLCWorld Business Lenders, LLC provides short-term collateralized commercial loans to small and medium-sized businesses throughout the United States. The company is a U.S.-based organization with a 100% remote workforce.This contract/consultancy position requires excellent English language skills and typically works...