Regulatory Affairs Chief

hace 3 días

Insurgentes CDMX, México AstraZeneca A tiempo completo

What You´ll Do:

  • Leadership and strategy

  • Defines and implements the regulatory team's strategic objectives, ensuring alignment with organizational goals and fostering collaboration.

  • Develops regulatory plans and strategies for new products and clinical line extensions, anticipating local and global requirements.
  • Serves as an internal consultant and facilitator to Quality and Operations teams, enabling efficient decision-making and execution
  • Reviews and ensures dossiers prepared by regulatory specialists are error-free and compliant with regulatory requirements.
  • Develops and implements Standard Operating Procedures (SOPs) to strengthen regulatory compliance and operational efficiency.
  • Ensures information systems related to regulatory submissions and approvals are consistently updated and maintained.
  • Oversees the review and approval of promotional materials, ensuring compliance with local and global standards and legal/quality requirements established by relevant authorities.
  • Reviews and approves final packaging artwork for assigned products, ensuring adherence to regulatory requirements and company standards.

  • Integrated lifecycle responsibilities

  • Collaborates across multidisciplinary teams during Launch Readiness Reviews, ensuring objective alignment and effective execution of regulatory plans.

  • Coordinates and presents product quality information to the New Molecules Committee, enabling informed assessments and decisions.
  • Actively engages with the regulatory environment, staying current with evolving regulations, guidance, and health authority expectations.
  • Provides or coordinates local health authority contact and support during queries, inspections, or information requests.
  • Participates as a member of the drug project team to enable timely approvals and advantageous product information, aligned with business and market needs and compliant with relevant procedures.
  • Contributes to the planning, preparation (including authoring) and delivery of simple submissions, and supports more complex ones from a global and/or regional perspective across the product lifecycle.
  • Proactively liaises with cross-functional teams, providing regulatory advice on straightforward issues; coordinates the review of cross-functional inputs and consolidates regulatory comments to ensure submission quality.
  • Ensures appropriate, up-to-date records are maintained for compliance.
  • Champions a culture of courageous leadership, creativity, and collaboration.

Essential for the role:

  • Professional degree related to the field (e.g. pharmacist, QFB, biotechnology)
  • Knowledge of health care regulations, laws and standards
  • Analytical, written and oral communications skills
  • Ability to work effectively in a team
  • Advanced English.
  • At least 5 years of experience within regulatory affairs or in a Health Authority
  • Good written and verbal communication skills
  • Performance Driven

Desirable:

  • Experience in vaccines, biotechnological and orphans product.
  • Experience with people management.

  • Regulatory Affairs Leader

    hace 1 semana

    Insurgentes, México Novartis A tiempo completo

    **Summary**:Garantiza un sistema de documentación controlado, retención de registros y servicios de información, incluidos los procesos de retención de registros electrónicos de acuerdo con los requisitos reglamentarios. Asegura el cumplimiento de los requisitos de las agencias reguladoras. Mantiene el sistema de cambio de documentación técnica y no...

  • Regulatory Affairs Specialist

    hace 1 semana

    Ciudad de México, CDMX Medtronic A tiempo completo

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Lead and prepare RA meetings (regulatory status) involving the OU's under their responsibility....

  • Spclst, Regulatory Affairs

    hace 7 días

    Ciudad de México, CDMX MSD A tiempo completo

    El **ESPECIALISTA SR. DE ASUNTOS REGULATORIOS** ayudará en las actividades regulatorias de productos para dar soporte a nuestra empresa **Competencias**: - Garantiza el mantenimiento de los productos asignados y autorizados mediante la presentación oportuna de prórrogas y modificaciones a las condiciones de registro sanitario. - Para productos y...

  • Regulatory Affairs

    hace 5 días

    Ciudad de México, CDMX Parexel A tiempo completo

    A Regulatory Affairs Associate must have a knowledge of the organization´s basic consulting models and methodologies as well as basic knowledge of what services the department provides. A Project Leader must be technically competent and continually developing the skills as defined in the department, under general direction of his/her Line Manager and...

  • Regulatory Affairs Leader

    hace 2 días

    Insurgentes, México Novartis A tiempo completo

    **Summary**:- Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place...

  • Regulatory Affairs Leader

    hace 4 días

    Insurgentes, México Novartis A tiempo completo

    **Summary**: - Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in...

  • Regulatory Affairs Specialist

    hace 1 día

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

    Regulatory Affairs Specialist Job description: Full time On-Site, 9:00AM to 6:00PM in Polanco CDMX, Mexico Immediate job! Chemist/ Biologist and also Pharmacist Diploma. Experience in Dossier preparation for Drug products: take care of the preparation of your dossier. Viewing, checking, preparing for submission to COFEPRIS, Printing, submitting. At...

  • Regulatory Affairs Jr. Specialist

    hace 1 día

    Ciudad de México, CDMX Johnson & Johnson A tiempo completo

    Declaración DE&I Durante más de 130 años, la diversidad, la equidad y la inclusión (DEI) han sido parte de nuestro tejido cultural en Johnson & Johnson y están integradas en la forma en que hacemos negocios todos los días. Arraigados en Nuestro Credo, los valores de DEI impulsan nuestra búsqueda de crear un mundo más saludable y equitativo. Nuestra...

  • Senior Manager, Development and Regulatory

    hace 4 días

    Ciudad de México, CDMX GSK A tiempo completo

    **Site Name**: Poznan Grunwaldzka, Mexico City Torre Mitikah, Mississauga Milverton Drive, Warsaw Rzymowskiego 53 **Posted Date**: Oct 31 2024 **Senior Manager, Development and Regulatory Operations** This role leads a group of Business System Owners (BSOs) at GlaxoSmithKline (GSK) and is responsible for overseeing the strategic management and continuous...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Insurgentes, México Novartis A tiempo completo

    **Summary**: Garantiza un sistema de documentación controlado, retención de registros y servicios de información, incluidos los procesos de retención de registros electrónicos de acuerdo con los requisitos reglamentarios. Asegura el cumplimiento de los requisitos de las agencias reguladoras. Mantiene el sistema de cambio de documentación técnica y no...