Regulatory Affairs Manager

hace 3 semanas


Ciudad de México, Ciudad de México Fyte A tiempo completo

Regulatory Affairs Manager CDMX

En Fyte estamos en búsqueda de un Regulatory Affairs Manager para una empresa farmacéutica internacional

Buscamos conectar con
Profesionales con al menos 10 años de experiencia laboral en Asuntos Regulatorios para la industria farmacéutica.

¿Qué responsabilidades tendrás?

  • Asegurar que todos los productos y procesos cumplan con las normativas locales e internacionales aplicables en México.
  • Supervisar la obtención y mantenimiento de licencias y autorizaciones regulatorias, asegurando la conformidad con las regulaciones aplicables.
  • Coordinar la preparación, revisión y presentación de la documentación regulatoria para nuevos productos, modificaciones, y renovaciones.
  • Asegurar la organización y el mantenimiento de archivos regulatorios, garantizando la accesibilidad y precisión de la información.
  • Actuar como el principal punto de contacto con las autoridades regulatorias en México, respondiendo a consultas y gestionando las solicitudes regulatorias de manera eficiente.
  • Desarrollar y ejecutar estrategias regulatorias que faciliten la aprobación de productos y aseguren el cumplimiento continuo con las regulaciones.
  • Anticipar riesgos regulatorios y proponer soluciones efectivas para mitigarlos.
  • Mantenerse actualizado sobre cambios en las normativas y regulaciones, adaptando las estrategias y procedimientos internos en consecuencia.
  • Participar en comités técnicos y brindar análisis de impacto sobre nuevas regulaciones y lineamientos.
  • Proporcionar capacitación y apoyo en materia de regulación a otros departamentos, incluyendo desarrollo de productos, marketing, y ventas.
  • Colaborar estrechamente con equipos internos y externos para asegurar la ejecución exitosa de estrategias regulatorias.
  • Facilitar la comunicación efectiva y mantener informados a los stakeholders clave sobre los avances y cambios regulatorios.

Requisitos:

  • Licenciatura en Ciencias Farmacéuticas, Ciencias de la Salud, o campos relacionados. Se valorará una Maestría en Asuntos Regulatorios o áreas afines.
  • Sólido conocimiento de las regulaciones y directrices aplicables a productos farmacéuticos de prescripción y dispositivos médicos (por ejemplo, RIS, LGS, NOM-072, NOM-073, NOM-059, NOM-220, NOM-241, NOM-137).
  • Mínimo de 10 años de experiencia en asuntos regulatorios, en la industria farmacéutica, biotecnológica o de dispositivos médicos.
  • Sólidas habilidades organizativas, de comunicación y gestión de proyectos.
  • Capacidad para trabajar de manera efectiva en un entorno híbrido y con equipos multidisciplinarios.
  • Habilidad para anticipar y resolver problemas regulatorios complejos.
  • Experiencia en la interacción con autoridades regulatorias y en la preparación de documentación para registros sanitarios.
  • Conocimiento profundo del marco regulatorio mexicano para productos farmacéuticos y dispositivos médicos.
  • Inglés avanzado (oral y escrito).


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

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Upfield in Mexico City. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory requirements in Central and Latin America.Key ResponsibilitiesDevelop and implement regulatory strategies to support product...


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

    Job DescriptionWe are seeking a highly skilled and experienced Regulatory Affairs professional to join our team at Gilead Sciences. As a Regulatory Affairs Manager, you will play a critical role in advancing our therapeutics and ensuring regulatory compliance.Key ResponsibilitiesDevelop and Execute Regulatory Strategies: Define, develop, and execute...


  • Ciudad de México, Ciudad de México Gilead Sciences, Inc. A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Gilead Sciences, Inc. in Mexico City. As a key member of our Regulatory Affairs team, you will play a critical role in advancing our therapeutics and ensuring regulatory compliance.Key ResponsibilitiesRegulatory Strategy DevelopmentDefine and execute regulatory...


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

    About GileadGilead is a leading biopharmaceutical company dedicated to creating a healthier world for all people. With over 35 years of experience, we have developed therapies that improve lives and ensure access to these therapies across the globe.We are a collaborative and ambitious team that tackles the world's biggest health challenges. Our employees are...


  • Ciudad de México, Ciudad de México Mccormick & Company A tiempo completo

    Job SummaryMccormick & Company, a leading manufacturer and distributor of spices, seasonings, and condiments, is seeking a highly skilled Regulatory Affairs Manager II to join our team in Mexico City, Mexico.About the RoleThe successful candidate will be responsible for leading a team of regulatory professionals who will develop and implement regulatory...


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

    Job SummaryThermo Fisher Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our Regulatory Liaison team. As a key member of our team, you will be responsible for 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 Thermo Fisher Scientific A tiempo completo

    **Job Summary**Thermo Fisher Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Liaison team, you will be responsible for leading on communications with regulatory agencies as part of centralized regulatory submissions.**Key Responsibilities**Provide regulatory advice and carry out...


  • Ciudad de México, Ciudad de México Fenixfarma Mexico City, Mexico A tiempo completo

    Job Title: Regulatory Affairs CoordinatorCompany: Fenixfarma Mexico City, MexicoJob Summary:We are seeking a highly skilled Regulatory Affairs Coordinator to join our team in Mexico City. The successful candidate will be responsible for ensuring compliance with local health regulations and leading a team of regulatory specialists to achieve product...


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

    About the OpportunityQuidelOrtho, a world-leading in vitro diagnostics company, is seeking a highly skilled Regulatory Affairs Associate to join our team. With a strong presence in over 130 countries, we provide fast, accurate, and consistent testing solutions where and when they are needed most.Our company culture prioritizes employee happiness,...


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

    Key Responsibilities:As a Regulatory Affairs Coordinator at MMATISS, you will be responsible for ensuring compliance with local regulations by performing submissions and tracking the progress of approvals. You will implement regulatory processes to avoid warnings or rejections, including obtaining protocol, site, marketing, and importation/exportation...


  • Ciudad de México, Ciudad de México Philips Iberica SAU A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Philips Iberica SAU. As a key member of our Regulatory Affairs team, you will be responsible for guiding and supporting our businesses, markets, and supporting functions in the Mexico market to ensure compliance with regulatory requirements.Key...


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

    Job SummaryWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at ICON plc. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the successful execution of clinical trials.Key ResponsibilitiesRegulatory Document Preparation...


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

    Job SummaryICON Plc is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a pivotal role in ensuring regulatory compliance and facilitating the successful execution of clinical trials.Key ResponsibilitiesRegulatory ComplianceLead the preparation, submission, and...


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

    Regulatory Affairs Specialist Role at GSKThis position is responsible for coordinating activities related to compliance with the Regulatory Framework in Mexico, aligned to the needs and strategies defined by the different participating areas of GSK, focused on the submission and approval of administrative and technical modifications.Key...


  • Naucalpan de Juárez, México Hydro - US Facilities A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Hydro - US Facilities. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to achieve regulatory approvals.Key ResponsibilitiesDevelop and implement regulatory strategies for...


  • Naucalpan de Juárez, México Merck Group A tiempo completo

    About the Role:We are seeking a highly skilled Regulatory Affairs Manager to join our team at Merck Group. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with local regulations and guidelines for our pharmaceutical products and medical devices.Key Responsibilities:Develop and implement regulatory strategies...


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

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Medtronic. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for medical devices in the LATAM region.Key ResponsibilitiesCoordinate and prepare document packages for regulatory submissions,...


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

    About KenvueKenvue, part of the Johnson & Johnson Family of Companies, is a leading healthcare company that believes in the extraordinary power of everyday care. With a rich heritage and propelled forward by science, our iconic brands are trusted by millions of consumers who use our products to improve their daily lives.Job SummaryWe are seeking a highly...


  • Ciudad de México, Ciudad de México Procter & Gamble A tiempo completo

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Procter & Gamble. As a key member of our regulatory team, you will be responsible for preparing and approving submission-ready documents for renewals, variations, or rollouts, maintaining existing product licenses for medicinal products or Food Supplements, and...


  • Ciudad de México, Ciudad de México Psi CRO Ag A tiempo completo

    At Psi CRO Ag, we are seeking a highly skilled Regulatory Officer to join our team of experts in regulatory and ethics submissions of clinical studies.Key ResponsibilitiesPrepare clinical trial submission dossiers for regulatory and ethics authorities, ensuring compliance with all relevant regulations and guidelines.Communicate effectively with regulatory...