Start-up & Regulatory Specialist

hace 3 semanas

Mexico City Fortrea A tiempo completo

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

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 Readiness team and that documentation meets the specifications required by applicable regulations and sponsor. Proactively interacts with EC/IRB/Third body/Regulatory Authorities to provide guidance regarding requirements. Maintain awareness of current regulatory standards related to submissions. Serve as local expert in project start-up activities for a particular country or region. Act as a ‘knowledge resource’ to mentor and train new hires and less-experienced department colleagues if suitable.

Summary of Responsibilities:

• Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries.

• Coordinate, collect and organize data and information required by EC/IRB/Third body/Regulatory Authority including but not limited to the preparation of study documentation such as the country application form and cover letter for sponsor review as applicable.

• Compile and prepare routine submission filed to IRB/IEC/Third body/Regulatory Authorities (e.g., INDs/CTAs) and liaise with them as applicable regarding submission/approval.

• Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).

• Perform a review of final submission documents as applicable.

• Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs and quality standards.

• Prevent and escalate study issues appropriately and in a timely fashion.

• Perform other duties as assigned by management depending upon country and situational requirements with proper supervision [if applicable].

• In Country specific tasks (Global):

• Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.

• Collect and track all the necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance without supervision.

• Ensure high quality documents are filed and systems are updated on an ongoing and timely basis, making Fortrea ready for an audit at any time.

• Participate in team and project meetings as applicable.

• When needed, assist in the strategy definition for Site Activation and provide accurate projections and timelines to study teams.

• Review and customize country and site-specific patient informed consent forms for compliance with local requirements and protocol. Proactively resolve informed consent issues and other potential difficulties with study sites.

• May support the negotiation of site contracts and budgets with sites, if applicable and track progress of contract and budget milestones/developments, intervening and escalating as appropriate.

• Proactively identifying and escalating to Submission Leads any risk to meeting deliverables.

• Notify the Submissions Lead of hours identified as Out-of-Scope or overburn.

• Clinical Trials Information System (CTIS) tasks (specific centralized role for EU): • Assist in the upload of submission documentation to, interacting with and monitoring of all notifications and alerts in CTIS to ensure all milestones and events for the trial are met within the timelines mandated.

• Performs all other duties as needed or assigned.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

  • Regulatory Specialist Latam

    hace 3 semanas

    Mexico City Red Bull A tiempo completo

    Company DescriptionThe legal team protects Red Bull, its people, partners and vendors by adding value to each product line and initiative. Legal is divided into Legal Business Partners for the Beverage Business and Corporate Projects, Specialist Departments and Centers of Expertise.The Regulatory Specialist assists the LATAM Regional team by offering...

  • Regulatory Specialist Latam

    hace 3 semanas

    Mexico City Red Bull A tiempo completo

    The legal team protects Red Bull, its people, partners and vendors by adding value to each product line and initiative. Legal is divided into Legal Business Partners for the Beverage Business and Corporate Projects, Specialist Departments and Centers of Expertise. The Regulatory Specialist assists the LATAM Regional team by offering technical and legal...

  • Regulatory Specialist 2, FSP

    hace 3 semanas

    Mexico City IQVIA A tiempo completo

    Job Overview 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. May also include maintenance activities. Essential Functions • Under general supervision,...

  • Regulatory Affairs Specialist

    hace 3 semanas

    Mexico City ProductLife Group A tiempo completo

    In the context of a new project, we are looking for a Regulatory Affairs Specialist to join our teams in Mexico/LATAM. Group 10 Responsibilities Provide guidance and support about Mexican and Central America legislation Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration...

  • Mgr, Reg

    hace 3 semanas

    Mexico City IQVIA A tiempo completo

    Job Overview Manages a regional work unit responsible for site activation. Sets goals and objectives for team members for achievement of short-term operational or tactical results. Essential Functions • Manages staff's delivery of site activation activities in accordance with organization’s policies and applicable regulations. Responsibilities...

  • Regulatory Affairs Specialist

    hace 3 semanas

    Mexico City Edwards Lifesciences A tiempo completo

    Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to...

  • Ctry Approval Assoc

    hace 3 semanas

    Mexico City Thermo Fisher Scientific A tiempo completo

    Essential Functions and Other Job Information:  Essential  Functions • Prepares, reviews and coordinates, under guidance and local EC submissions in  alignment with global submission strategy.  • Supports preparation, under guidance, of local MoH submissions, as applicable in  alignment with global submission strategy. • Coordinates, under...

  • Site Activation Specialist

    hace 3 semanas

    Mexico City IQVIA A tiempo completo

    Site Activation Specialist for External Commerce (ComEx) - Homebased Essential Functions • Responsible for importations and exportation activities in Mexico for our FSP model • Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. • Perform start up and site...

  • (Assoc) Global Site Activation Analyst in LATAM

    hace 3 semanas

    Mexico City IQVIA A tiempo completo

    Manages and executes the site identification process and performs regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements either at the global, regional, or country level. Prepares and manages site regulatory documentation; reviews and negotiates site regulatory documents and contracts with sites...

  • Ctry Approval Assoc

    hace 2 semanas

    Mexico City Thermo Fisher Scientific A tiempo completo

    Job DescriptionEssential Functions and Other Job Information: Essential Functions• Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. • Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy.•...

  • Supply Chain Specialist

    hace 1 semana

    Mexico City Align Technology A tiempo completo

    About this opportunity The Supply Chain Specialist is an experienced logistician with extensive operational and process improvement knowledge, covering international shipping, customs clearance, warehousing and domestic distribution. In this role, you will… • Partner global and regional teams to manage operations and fulfilment of our products and...

  • Associate, Legal

    hace 1 semana

    Mexico City Vanguard A tiempo completo

    About VanguardFounded in 1975, Vanguard is one of the world's leading investment management companies. The firm offers investments, advice, and retirement services to individual investors, institutions, and financial professionals. Vanguard operates under a unique, investor-owned structure where Vanguard fund shareholders own the funds, which in turn own...

  • Pricing Analyst Specialist

    hace 2 semanas

    Mexico City KAVAK A tiempo completo

    Si quieres pertenecer a un equipo que mueve la operación tanto nacional como internacional, KAVAK es tu lugar. Somos la startup privada de mayor valuación de Latam y el 1er unicornio Mexicano. Invertimos en talento, ideas, infraestructura y tecnología para seguir revolucionando la compra y venta de autos en el mundo. Queremos garantizar que nos...

  • Safety Specialist

    hace 3 semanas

    Mexico City Thermo Fisher Scientific A tiempo completo

    Summarized Purpose:  Performs day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment  and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection,  monitoring, assessment, evaluation, research and tracking of safety information. Coordinates and  performs Pharmacovigilance...

  • Provisioning Specialist

    hace 3 semanas

    Mexico City Outreach A tiempo completo

    About The Team We are looking for a Provisioning Specialist to join the Outreach Finance team. If you are customer service oriented, detailed, and enjoy a fast paced environment where things are evolving and there’s ton to learn, please apply! We can’t wait to meet you. The Role As a Provisioning Specialist you will be responsible for provisioning...

  • Senior Risk

    hace 2 semanas

    Mexico City Nestlé A tiempo completo

    About IT In Nestlé We are a team of IT professionals from many countries and diverse backgrounds, each with unique missions and challenges in the biggest health, nutrition and wellness company of the world. We innovate every day through forward-looking technologies to create opportunities for Nestlé’s digital challenges with our consumers, customers...

  • Investigator Service Analyst

    hace 1 semana

    Mexico City IQVIA A tiempo completo

    We are looking for a Contract Coordinator to join our Sponsor Dedicated model! Location: Mexico - Hybrid role. What You´ll Do Support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by either the agreed algorithm or the Sponsor’s requirements, including...

  • Senior Specialist

    hace 3 semanas

    Mexico City Fortrea A tiempo completo

    The Clinical & Ancillary Supplies Services (CASS) Senior Specialist: Coordinate and oversee aspects of logistics related to Clinical and Ancillary Supplies services. Support these services to both internal and external clients. Responsible for the set-up and coordination of project activities related to clinical and ancillary supplies Independently...

  • R2R Specialist

    hace 3 semanas

    Mexico City MX19 Alcon Laboratorios S.A. De C.V. Company A tiempo completo

    R2R Specialist At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in...

  • Collections Specialist

    hace 3 semanas

    Mexico City TikTok A tiempo completo

    Team Introduction The Revenue BP and Credit Control team is responsible for the revenue contract review of the company's overall business lines. Position OverviewTikTok is seeking a stellar Collections Specialist to join our Mexico office. In this role, you will handle AR-related activities and improve debt collection processes in the LATAM region, among...