Empleos actuales relacionados con Regulatory Affairs Specialist - Ciudad de México, Ciudad de México - GSK

  • Regulatory Affairs Specialist

    hace 2 meses

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

    Regulatory Affairs SpecialistThermo 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...

  • Regulatory Affairs Specialist

    hace 7 días

    Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    Regulatory 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...

  • Regulatory Affairs Specialist

    hace 1 mes

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

    Regulatory Affairs SpecialistThermo 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 play a critical role in leading communications with regulatory agencies and providing regulatory affairs strategy and technical/project leadership on a regional/global...

  • Regulatory Affairs Specialist

    hace 3 semanas

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

    Regulatory Affairs SpecialistThermo 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 on communications with regulatory agencies as part of centralized regulatory submissions, including the EU CTR process.Key...

  • Regulatory Affairs Specialist

    hace 7 días

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

    In this role as a Regulatory Affairs Specialist, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions. You will partner with our Regulatory Affairs leads, in providing regulatory affairs strategy and technical/project leadership on a regional/global level.Key...

  • Regulatory Affairs Specialist

    hace 4 días

    Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    We 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 Affairs Specialist

    hace 1 mes

    Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group in Mexico/LATAM.Key ResponsibilitiesProvide expert guidance and support on Mexican and Central America legislation to ensure compliance with regulatory requirements.Contribute to the development and implementation of regulatory...

  • Regulatory Affairs Specialist

    hace 2 meses

    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...

  • Regulatory Affairs Specialist

    hace 7 días

    Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    We are seeking a Regulatory Affairs Specialist to ensure the delivery of regulatory activities on a global level.Key ResponsibilitiesContribute to the production of client administrative documents for regulatory submissions.Compile regulatory dossiers in accordance with national requirements.Manage systems and administer regulatory processes.Track and...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    In the context of a new project, we are seeking a Regulatory Affairs Specialist to support our teams in Mexico/LATAM.Key ResponsibilitiesProvide guidance and support on Mexican and Central America legislation.Contribute to regulatory activities, including pre-licensing, new registrations, and post-licensing submissions.Assist in the production of client...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    Regulatory Affairs Officer Job DescriptionWe are seeking a highly skilled Regulatory Affairs Officer to join our team at ProductLife Group. As a key member of our regulatory team, you will be responsible for ensuring the delivery of regulatory activities on a global level.Responsibilities:Contribute to the production of client administrative documents for...

  • Regulatory Affairs Specialist

    hace 4 semanas

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

    Position for Novo Nordisk GBS MexicoWe are seeking a highly skilled Regulatory Affairs Coordinator to join our team in GBS Mexico City. As a key member of our global business service centre, you will play a critical role in ensuring compliance with regulatory standards and supporting our global operations.The RoleAs a Regulatory Affairs Coordinator, you will...

  • Regulatory Affairs Specialist

    hace 3 semanas

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

    Position for Novo Nordisk GBS MexicoWe are seeking a highly skilled Regulatory Affairs Coordinator to join our team in GBS Mexico City. As a key member of our team, you will play a crucial role in ensuring compliance with regulatory standards and supporting our global operations.The RoleAs a Regulatory Affairs Coordinator, you will be responsible...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    Regulatory Affairs Officer Job DescriptionWe are seeking a highly skilled Regulatory Affairs Officer to join our team at ProductLife Group. As a key member of our regulatory team, you will be responsible for ensuring the delivery of regulatory activities on a global level.Key Responsibilities:Contribute to the production of client administrative documents...

  • Regulatory Affairs Professional

    hace 4 días

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

    The Regulatory Affairs Specialist will contribute to the preparation, compilation, and submission of regulatory documents, including CT/IND, MAA, and NOA. Key Responsibilities:- Regulatory Document Preparation: Prepare and submit regulatory documents in a timely and accurate manner.- Collaboration with Teams: Work with the Regulatory Submissions team and...

  • Regulatory Affairs Specialist

    hace 4 semanas

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

    Position for Novo Nordisk GBS MexicoWe are seeking a highly skilled Regulatory Affairs Coordinator to join our team in GBS Mexico City. As a key member of our team, you will be responsible for supporting the compilation, submission, and approval of Country Specific Submissions files for responsible countries.The RoleProvide regulatory support to affiliates...

  • Regulatory Affairs Specialist

    hace 1 mes

    Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    Regulatory Affairs OfficerProductLife Group is seeking a highly skilled Regulatory Affairs Officer to manage post-MAA activities for the Canadian market.ResponsibilitiesManage post-approval activities (Life Cycle Management) for the Canadian market, ensuring compliance with Health Canada guidelines.Initiate change controls, including regulatory assessments...

  • Regulatory Affairs Specialist

    hace 1 semana

    Ecatepec de Morelos, México Philips A tiempo completo

    **Job Title**: Regulatory Affairs SpecialistAt Philips, we're committed to improving billions of lives worldwide through innovation. As a Regulatory Affairs Specialist, you'll play a crucial role in ensuring our medical and non-medical products meet regulatory requirements in Mexico and Latin America.**Key Responsibilities:**Communicate Mexico-specific...

  • Regulatory Affairs Specialist

    hace 1 semana

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

    **Scientific and Regulatory Affairs Manager LATAM**Mccormick & Company, a world leader in the spice, flavor and seasonings industry, is seeking a full time Scientific and Regulatory Affairs Manager LATAM. This new hire will work in our Mexico City location.We create differentiating flavors consumers prefer with unmatched quality, science, innovation and...

  • Regulatory Affairs Specialist

    hace 3 semanas

    Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    Regulatory Affairs Officer Job DescriptionWe are seeking a highly skilled Regulatory Affairs Officer to join our team at ProductLife Group. As a key member of our regulatory team, you will be responsible for ensuring the delivery of regulatory activities on a global level.Responsibilities:Contribute to the production of client administrative documents for...

Regulatory Affairs Specialist

hace 2 meses

Ciudad de México, Ciudad de México GSK A tiempo completo

Regulatory Affairs Specialist Role at GSK

This 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 Responsibilities:

  • Ensure knowledge and compliance with local and/or corporate, national and/or international laws, policies, and guidelines applicable to the position.
  • Participate actively in projects to improve the area and site, driving process improvements and efficiency.
  • Comply with the training and development plan assigned to the position, staying up-to-date with regulatory requirements.
  • Develop regulatory strategies (Third Parties, Demand, and Commercial) together with the Regulatory Affairs Manager, ensuring alignment with business objectives.
  • Provide local or international contacts with the specific requirements of the Mexican market, facilitating effective communication and collaboration.
  • Coordinate and execute activities related to the preparation and submission to the Ministry of Health in Mexico on:
    • Registration renewals.
    • Variations to the registration conditions: change in formula, active ingredient, manufacturing process, packaging, shelf-life extension, line extensions, manufacturing sites, and new indications.
    • Product Information update.
    • Specific cases such as technical queries, meetings, etc.
    • Responses to the Health Authority Questions.
    • Monitoring and response to commitments.
  • Update information in the dossier in accordance with Mexican Regulation, ensuring accuracy and completeness.
  • Maintain and update applicable systems (Submission Plan, Veeva, Filestorage, etc.), ensuring data integrity and security.

Required Qualifications:

  • Professional background in pharmaceutical chemistry or related field.
  • 1 year of experience in regulatory affairs or release of biological products.
  • Knowledge of Office package.
  • Intermediate to advanced level of English.
  • Experience in Pharma.