Regulatory Affairs Expert for Clinical Trials with Senior Leadership

hace 2 semanas


Ciudad de México, Ciudad de México ICON Plc A tiempo completo

Job Summary

We are seeking a seasoned Regulatory Affairs Specialist to lead the preparation, submission, and maintenance of regulatory documents for clinical trials. The ideal candidate will have extensive experience in the pharmaceutical or biotech industry and possess strong knowledge of global regulatory requirements and guidelines.

About the Role

  • Develop and implement strategies to ensure compliance with regulatory standards and mitigate risks associated with clinical trials.
  • Collaborate with internal teams to provide expertise and guidance on regulatory requirements and standards.
  • Interface with regulatory agencies to address inquiries, submissions, and approvals.
  • Monitor changes in regulations and guidelines to stay up-to-date and ensure compliance.

Your Profile

  • Bachelor's degree in a scientific or related field; advanced degree preferred.
  • Minimum of 2 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
  • Strong knowledge of global regulatory requirements and guidelines for clinical trials.
  • Proven ability to manage regulatory submissions and interactions with regulatory agencies.
  • Excellent communication, attention to detail, and problem-solving skills.

What We Offer

  • A competitive salary of approximately $120,000 per year.
  • An attractive benefits package including various annual leave entitlements, health insurance options, and retirement planning offerings.
  • The opportunity to work with a world-leading healthcare intelligence and clinical research organization like ICON Plc.

  • 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 Plc A tiempo completo

    Senior Regulatory Affairs SpecialistWe're seeking a highly skilled Clinical Trials Regulatory Affairs Expert to join our team at ICON Plc. This is an exciting opportunity to leverage your expertise in regulatory affairs and contribute to the success of our clinical trials.About the Role:Lead the preparation, submission, and maintenance of regulatory...


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

    At ICON, we are seeking a Senior Regulatory Affairs Specialist to join our team in Mexico City.The ideal candidate will have a strong background in clinical trials and regulatory affairs, with experience in preparing and submitting regulatory documents.We offer a competitive salary of $95,000 per year, plus benefits such as annual leave entitlements, health...


  • Ciudad de México, Ciudad de México ICON plc A tiempo completo

    At ICON plc, we're seeking a skilled Senior Regulatory Affairs Specialist with experience in clinical trials to join our team.This role will play a pivotal part in ensuring regulatory compliance and facilitating the successful execution of clinical trials, contributing to the advancement of innovative treatments and therapies.The estimated salary for this...


  • 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 ENGINEERINGUK A tiempo completo

    We are seeking a seasoned Clinical Trials Regulatory Affairs Specialist to join our team at ICON plc, a world-leading healthcare intelligence and clinical research organization. Located in Mexico City, this role offers a unique blend of work flexibility and professional growth opportunities.About the Role:The successful candidate will play a pivotal part in...


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

    We are seeking a highly organized and detail-oriented Clinical Operations Specialist to join our team at Worldwide Clinical Trials.About the Role:The Clinical Operations Specialist will be responsible for ensuring all daily aspects of operational work related to rater selection, certification/qualification, training content, scale acquisition, surveillance...


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

    Company Overview:Worldwide Clinical Trials (WCT) is a leading global contract research organization that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications.The company has a dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, which...


  • Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    In a pivotal role at Thermo Fisher Scientific, the Sr Regulatory Affairs Specialist will be part of our Regulatory Liaison team, spearheading communications with regulatory agencies as part of centralized regulatory submissions. This includes collaboration with regulatory affairs leads to provide strategic guidance and technical/project leadership on a...


  • Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    In the role of Regulatory Affairs Strategist at Thermo Fisher Scientific, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions including but not limited to the EU CTR process. You will partner with our Regulatory Affairs leads, in providing regulatory affairs...


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

    Job 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...


  • Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    Job SummaryWe are seeking a highly skilled Sr Regulatory Affairs Specialist to join our team at Thermo Fisher Scientific. As a key member of our Regulatory Liaison team, you will play a critical role in leading communications with regulatory agencies and providing regulatory affairs strategy and technical/project leadership on a regional/global level.Key...


  • 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 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 Ortho Clinical Diagnostics A tiempo completo

    The 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...


  • Ciudad de México, Ciudad de México MEX Fortrea Clinical Development Mexico A tiempo completo

    **About MEX Fortrea Clinical Development Mexico**: We are a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. Our team provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions...


  • Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completo

    We are seeking a Senior Clinical Trials Specialist to join our team in Mexico.About the RoleThe Senior Clinical Trials Specialist will be responsible for ensuring compliance with importation and exportation laws, maintaining close communication with CDC TMs, anticipating potential risks, and safeguarding company resources.Key ResponsibilitiesBe the main...


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

    Job Description:We are seeking a highly skilled and experienced Senior Clinical Trials Assistant to join our team at IQVIA in Mexico City.Role Summary:The successful candidate will lead and oversee the execution of clinical projects and research studies in accordance with global and local regulations, ensuring compliance with contract, SOPs, GCPs, policies,...


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

    Worldwide Clinical Trials (Worldwide) is a leading global contract research organization that works in partnership with biotechnology and pharmaceutical companies to create customized solutions for advancing new medications.We are seeking a highly skilled Clinical Assessment Specialist to join our team. As a key member of the Clinical Assessment Technologies...


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

    Job OverviewAs a Regulatory Compliance Specialist, you will play a crucial role in ensuring that clinical trials are conducted in accordance with regulatory requirements and guidelines. Under moderate supervision, you will execute the feasibility, site identification, regulatory, start-up, and maintenance activities at the regional or country level.Key...