Regulatory and Start-Up Specialist
hace 1 mes
Job Overview
We are seeking a highly skilled Regulatory and Start-Up Specialist to join our team at IQVIA. As a key member of our FSP team, you 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.
Key Responsibilities
• Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Perform start-up and site activation activities according to applicable regulations, SOPs, and work instructions.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
• Review and provide feedback to management on site performance metrics.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• 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.
Requirements
• Bachelor's Degree in life sciences.
• +3 years of clinical research experience within regulatory area: submissions, knowledge of ICF, presentations to ethics committee, COFEPRIS.
• Fluent English: written and oral communication skills.
-
Regulatory and Start-Up Expert
hace 1 semana
Ciudad de México, Ciudad de México IQVIA A tiempo completoRegulatory & Start Up SpecialistWe are seeking a skilled Regulatory & Start Up Specialist to join our cFSP team in a Home Based role.Location: Argentina & MéxicoJob 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...
-
Regulatory and Start-Up Specialist 2, cFSP
hace 1 mes
Ciudad de México, Ciudad de México IQVIA A tiempo completoSite Management Specialist, Regulatory and Start-UpLocation: RemoteJob OverviewThis position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a point of contact for investigative sites and the study team members. This includes supporting site qualification, site level regulatory green light and...
-
Regulatory and Compliance Specialist MEX
hace 3 semanas
Ciudad de México, Ciudad de México IQVIA A tiempo completoWe 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...
-
Regulatory Compliance Specialist
hace 1 mes
Ciudad de México, Ciudad de México MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completoJob OverviewMEX Labcorp Clinical Development, S. de R.L. de C.V. is seeking a highly motivated Regulatory Compliance Specialist to join our team. As a key member of our clinical development team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the assigned countries.Key Responsibilities:Maintain awareness of...
-
Regulatory Affairs Specialist
hace 4 semanas
Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completo**About the Role**We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Worldwide Clinical Trials. As a key member of our team, you will be responsible for planning, initiating, and tracking documents required for regulatory submissions, essential documents collection, review, and provision of country/site/EC requirements to...
-
Regulatory Affairs Specialist
hace 3 semanas
Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completo**Role Overview**At Worldwide Clinical Trials, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for planning, initiating and tracking documents required for regulatory submissions, essential documents collection, review and provision of country/site/EC requirements to support achievement of site...
-
Regulatory Compliance Specialist
hace 2 días
Ciudad de México, Ciudad de México MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completoAs 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...
-
Regulatory Submissions Manager
hace 1 mes
Ciudad de México, Ciudad de México National Museum of Wildlife Art A tiempo completoRegulatory 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...
-
EHS/HSE Content Manager and Regulatory Specialist
hace 3 semanas
Ciudad de México, Ciudad de México ERM A tiempo completoEHS/HSE Content Manager and Regulatory SpecialistAt ERM, we're redefining the way organizations manage their environmental, health, and safety (EHS) regulatory requirements. We're looking for a skilled EHS/HSE Content Manager and Regulatory Specialist to join our team and help us achieve our mission. About the RoleThis is a senior-level position that...
-
Site Start-Up
hace 4 semanas
Ecatepec de Morelos, México Syneos Health Clinical A tiempo completoAbout the RoleSyneos Health Clinical is seeking a highly skilled Site Start-Up & Regulatory Specialist I to join our team in Mexico. As a key member of our start-up team, you will be responsible for providing quality on deliverables at the country level and following project requirements and applicable country rules.Key ResponsibilitiesWorks within the...
-
Regulatory Affairs Specialist
hace 3 semanas
Ciudad de México, Ciudad de México ProductLife Group A tiempo completoWe are seeking a Regulatory Affairs Specialist to contribute to ensuring the delivery of regulatory activities on a global level.Key Responsibilities:To assist in the production of client administrative documents for regulatory submissions.To compile regulatory dossiers in accordance with national requirements and ensure their accuracy.To manage systems and...
-
Regulatory and Business Development Expert
hace 3 semanas
Ciudad de México, Ciudad de México IQVIA A tiempo completoRegulatory & 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...
-
Regulatory Specialist for Clinical Research
hace 1 mes
Ciudad de México, Ciudad de México IQVIA A tiempo completoWe are seeking a highly skilled Regulatory Specialist to join our team in a Home Based role Location : Argentina & México 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 requirements...
-
Regulatory Affairs Specialist
hace 4 semanas
Ciudad de México, Ciudad de México ProductLife Group A tiempo completoRegulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group. As a Regulatory Affairs Specialist, you will be responsible for managing post-approval activities for the Canadian market, including life cycle management, change controls, and regulatory submissions.Key Responsibilities:Manage...
-
Clinical Trials Regulatory Manager
hace 5 días
Ciudad de México, Ciudad de México National Museum of Wildlife Art A tiempo completoAbout 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...
-
Regulatory Compliance and Litigation Specialist
hace 2 días
Ciudad de México, Ciudad de México Kansas City Southern A tiempo completoAre you a seasoned professional with expertise in regulatory compliance and litigation? We are seeking a highly skilled Regulatory Compliance and Litigation Specialist to join our team at Kansas City Southern.About UsWe are a leading transportation company operating in North America, connecting Canada, the U.S., and Mexico through our extensive rail network....
-
Clinical Trials Specialist
hace 4 días
Ciudad de México, Ciudad de México MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completoJob OverviewMEX Labcorp Clinical Development, S. de R.L. de C.V. is seeking a highly skilled Regulatory Specialist to play a key role in the success of our clinical trials. As a Regulatory Specialist, you will be responsible for ensuring compliance with regulatory requirements and guidelines, coordinating with investigative sites, and maintaining awareness...
-
Regulatory Submissions Manager
hace 4 días
Ciudad de México, Ciudad de México National Museum of Wildlife Art A tiempo completoWe 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...
-
Regulatory Affairs Specialist
hace 1 mes
Ciudad de México, Ciudad de México Ortho Clinical Diagnostics A tiempo completoThe OpportunityAt Ortho Clinical Diagnostics, we are committed to delivering innovative solutions that transform the power of diagnostics into a healthier future for all. We are seeking a highly skilled Regulatory Affairs Associate to join our team and contribute to our mission.Key ResponsibilitiesPrepare and submit regulatory documents, including technical...
-
Regulatory Compliance Specialist
hace 4 días
Ciudad de México, Ciudad de México IQVIA A tiempo completoJob OverviewUnder moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional or country level.Key ResponsibilitiesEnsures pharmacovigilance processes applicable to Research Sites are executed as per guidelines.Submits...