Regulatory Affairs Coordinator

hace 7 días

Delegación Cuajimalpa de Morelos, Ciudad de México Takeda Pharmaceutical A tiempo completo

Regulatory Affairs Coordinator

  • English version_

WHAT YOU WILL DO


This position will be coordinate the activities derived from the Regulatory Affairs Managers to comply with and monitor the strategy and regulatory plan in accordance with the company's objectives.

This role reports to the Regulatory Affairs Manager and is based in México City, México.

WHAT YOU WILL WORK ON

  • Actively work with the Regulatory Affairs Manager to ensure planning, monitoring, alignment and compliance with regulatory deadlines.
  • Integrate the legal, clinical and technical documentation for the regulatory files of new products, postauthorization commitments and compliance with the life cycle (variations and renewals) of the products, in collaboration with the global regulatory leaders and with the local multidisciplinary team.
  • Evaluate global control changes in compliance with local legislation and corporate policies.
  • Manage local control chanfes for Regulatory Affairs.
  • Maintian legal documents updated (CPP, GMPs, PoAs...)
  • Prepare regulatory responses to answer Health Authority queries.
  • Evaluate together with the Manager the impact of regulatory strategies and their actions in accordance with the legal framework and global policies.
  • Review and evaluate legal initiatives and changes in health legislation, measure their impact and report to global and local teams.

WHO ARE WE LOOKING FOR

Experience & Education

  • Bachelor's in Chemicalmedicalbiological areas.
  • Office packaging
  • 3 years of experience in Regulatory Affairs area.
  • Desirable management of biological, biotechnological and orphan drug products.
  • Advanced English.
  • Knowledge of national and international health regulations.
  • Management, preparation and control of legal, technical and clinical documentation.
  • Management of pharmacopoeias
  • Requeriments analysis for the registration of pharmaceutical products in Mexico and/or Central America.
  • Experience in the New Molecules Committee and Subcommittee for the Evaluation of Biotechnological Products.

Competences & Skills

  • Analysis and decisionmaking processes.
  • Strategy planning.
  • Committed with foster diversity, equity and inclusive environment.

LOCATION:
México City, México.

_ Versión Español_

PROPOSITO DEL ROL


La posición será responsable de coordinar las actividades derivadas de las Gerencias de Asuntos Regulatorios para dar cumplimiento y seguimiento de la estrategia y plan regulatorio en concordancia con los objetivos de la compañía.

La posición reporta a la Gerencia de Asuntos Regulatorios y está basada en Ciudad de México, México.

DESAFIOS EN LA POSICIÓN

  • Trabajar activamente con la Gerencia de Asuntos Regulatorios para garantizar la planificación, seguimiento, alineación y cumplimiento de tiempos regulatorios.
  • Integrar la documentación legal, clínica y técnica que componen los expedientes regulatorios de los productos nuevos, compromisos postautorización y el cumplimiento del ciclo de vida (modificaciones y renovaciones) de los productos, en colaboración con los líderes regulatorios globales y con el equipo local multidisciplinario.
  • Evaluar los controles de cambio globales en cumplimiento con la legislación local y políticas corporativas.
  • Gestionar los controles de cambio locales de Asuntos Regulatorios.
  • Mantener actualizados los documentos legales (CPP, GMPs, PoAs).
  • Evaluar junto con la Gerencia el impacto de las estrategias regulatorias y sus acciones en concordancia con el marco legal y políticas globales.
  • Revisar y evaluar iniciativas de ley y cambios en la legislación sanitaria, medir su impacto e informar a los equipos globales y locales.

A QUIEN BUSCAMOS

Experiência y educación

  • Licenciatura en áreas Químicomédicobiológicas.
  • Manejo del Paquete Office.
  • 3 años de experiência en el área de Asuntos Regulatorios.
  • Deseable manejo de productos biológicos, biotecnológicos y medicamentos huérfanos.
  • Inglés avanzado.
  • Conocimiento en la regulación sanitaria nacional e internacional.
  • Manejo, elaboración y control de documentación legal, técnica y clínica.
  • Manejo de farmacopeas.
  • Análisis de requisitos para el registro de productos farmacéuticos en México y/o Centro América.
  • Experiência en los Comité de Moléculas Nuevas y Subcomité de Evaluación de Productos Biotecnológicos.

Competencias y habilidades

  • Capacidad analítica y enfocada a la toma de decisiones.
  • Persona orientada a resultados y resolución de problemas.
  • Compromiso con fomentar la diversidad, la equidad y el entorno inclusivo.

UBICACIÓN:
Ciudad de México, México.

Locations:

MEX - Santa Fe

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time

  • Regulatory Affairs Analyst

    hace 7 días

    Ciudad de México, Ciudad de México Viatris A tiempo completo

    Regulatory Affairs Analyst (Fixed Term) page is loaded Regulatory Affairs Analyst (Fixed Term) Postuler locations Mexico City, Mexico time type Temps plein posted on Offre publiée hier job requisition id R Viatris Healthcare México S. de R.L. de C.V Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous...

  • Regulatory Affairs Officer

    hace 7 días

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

    Regulatory Affairs Officer - 082 In the context of additional activities for one of our main clients, we are looking for a Regulatory Affairs Officer working from Mexico or Canada to manage post-MAA activities (Life Cycle Management) for the Canadian market. Group 10 Responsibilities Management of post approval activities (Life Cycle Management) for the...

  • Regulatory Affairs Analyst

    hace 7 días

    Ciudad de México, Ciudad de México HSBC A tiempo completo

    If you're looking for a career where you can make a real impression, join our Global Service Center - HSBC and discover how valued you'll be. We are currently seeking an experienced professional to join our team in the role of Regulatory Affairs Analyst Role Purpose: Regulatory Affairs Team supports the Compliance Function on a Global level,...

  • Analyst, Regulatory Affairs

    hace 7 días

    Ciudad de México, Ciudad de México Olympus Corporation of the Americas A tiempo completo

    Ubicación MEXICO, MEXICO CITY¿Está buscando una empresa que se preocupe por la vida y la salud de las personas, incluida la suya? Inspiremos vidas más saludables, juntosOlympus, una empresa líder en tecnología médica, se ha centrado en mejorar la vida de las personas durante más de 100 años.Nuestro propósito es hacer que la vida de las personas sea...

  • Regulatory Affairs Manager Ii

    hace 7 días

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

    Scientific and Regulatory Affairs Manager LATAMMcCormick & Company, Inc., 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, Mexico location.With more than $6 billion in annual sales, the McCormick manufactures markets and distributes...

  • Regulatory Affairs Specialist

    hace 7 días

    Ciudad de México, Ciudad de México Abbott A tiempo completo

    The Opportunity We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people. Our rapid diagnostics solutions are helping address some of the world's...

  • Regulatory Affairs Specialist

    hace 1 semana

    Ciudad de México, Ciudad de México Abbott Laboratories A tiempo completo

    Regulatory Affairs Specialist / Rapid Diagnostics page is loaded Regulatory Affairs Specialist / Rapid Diagnostics Apply locations Mexico - Cuidad de Mexico - Cuidad de Mexico time type Full time posted on Posted 3 Days Ago job requisition id JOB DESCRIPTION:Regulatory Affairs SpecialistMexico CityAbout AbbottAbbott is a global healthcare leader, creating...

  • International Regulatory Affairs Director

    hace 7 días

    Ciudad de México, Ciudad de México AstraZeneca A tiempo completo

    At AstraZeneca, we make a difference every day by delivering life-changing medicines to millions of people globally. Creating a more agile and inclusive environment means building an inspiring culture where we celebrate innovative thinking. This means we are opening up new ways to work, ground-breaking methods and bringing excellent teams together. Above...

  • Regulatory Affairs Qro

    hace 7 días

    Ciudad de México, Ciudad de México Tata Consultancy Services A tiempo completo

    We are a multinational company in the technology consulting and services field, with presence in 46 countries and more than 600,000 employees.Our company is looking for an Regulatory Affairs, Functions to join the team:Required Experience:- COMPLETE YOUR APPLICATION THAT WILL BE SENT BY MESSEGE ON INDEED:Regulatory advice to drug development is key to...

  • Regulatory Affairs Specialist

    hace 1 semana

    Ciudad de México, Ciudad de México Atos A tiempo completo

    Publication Date:May 25, 2023RefNo:481413Location:Mexico, D.F., Distrito Federal, MX, 2300The future is our choiceAt Atos, as the global leader in secure and decarbonized digital, our purpose is to help design the future of the information space. Together we bring the diversity of our people's skills and backgrounds to make the right choices with our...

  • Senior Specialist Regulatory Affairs

    hace 7 días

    Ciudad de México, Ciudad de México Qiagen A tiempo completo

    OverviewAt the heart of QIAGEN's business is a vision to make improvements in life possible.We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.Our...

  • International Regulatory Affairs Director

    hace 1 semana

    Ciudad de México, Ciudad de México OPENLANE A tiempo completo

    Are you a strategically focussed Regulatory professional with international (Asia, Latin America, Middle East, Africa, Eurasia) experience, and would like to play an integral part in bringing life changing medicines to patients? If you are please read on.At AstraZeneca, we make a difference every day by delivering life-changing medicines to millions of...

  • Manager, Regulatory Affairs

    hace 7 días

    Ciudad de México, Ciudad de México Biogen A tiempo completo

    Job Description:About This RoleReporting to the Sr. Manager, Regulatory affairs, the Manager supports all regulatory strategies creating tactics for new products at local and global levels.What you will do: Responsible for precise and aligned communication with local teams and global Regulatory team. Coordinate all postregistration changes for registered...

  • Regulatory Affairs Trainee

    hace 7 días

    Ciudad de México, Ciudad de México GSK A tiempo completo

    Site Name: Mexico City Torre MitikahPosted Date: Jun Regulatory Affairs, Trainee, 2023Hybrid model: 2 days on site per weekHelp us get ahead of disease together with our Regulatory Affairs areaEducation required: University Degree in a Pharmacobiologist Chemist, Pharmaceutical Engineer, or related fieldOther requirements:Availability of 8 hours (flexible)...

  • Regulatory Affairs Manager

    hace 4 semanas

    Ciudad de México, Ciudad de México AbbVie A tiempo completo

    Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...

  • Regulatory Affairs Manager

    hace 3 semanas

    Ciudad de México, Ciudad de México AbbVie A tiempo completo

    Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...

  • Senior Associate Regulatory Affairs

    hace 7 días

    Ciudad de México, Ciudad de México Amgen Inc. (IR) A tiempo completo

    Senior Associate Regulatory Affairs (1-Year Fixed Term) page is loaded Senior Associate Regulatory Affairs (1-Year Fixed Term) Apply remote type Flex Commuter / Hybrid locations Mexico - Mexico City time type Full time posted on Posted 5 Days Ago job requisition id R Career CategoryRegulatoryJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?If you feel like...

  • Regulatory Affairs Specialist

    hace 7 días

    Ciudad de México, Ciudad de México Johnson & Johnson SA de CV A tiempo completo

    Regulatory Affairs Specialist- WDescripciónEn Johnson & Johnson, la compañía de cuidado de la salud más grande del mundo, nos unimos con un propósito: transformar la historia de la salud en la humanidad.La diversidad y la inclusión son esenciales para continuar construyendo nuestra historia de pioneros e innovación, que ha estado impactando la salud...

  • Regulatory Affairs Specialist

    hace 7 días

    Ciudad de México, Ciudad de México Novartis A tiempo completo

    Bringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative digital technology. As a global company, the resources and opportunities for growth and development are plentiful including global and local cross-functional careers, a diverse learning suite of thousands of programs & an...

  • Regulatory Affairs Coordinator

    hace 1 semana

    Ciudad de México, Ciudad de México ABBVIE A tiempo completo

    Function/Mission: Coordinate all the required activities for label update based on reference label in order to submit to the local Health Authority according to KPIs timelines. Execute the review and approval process of advertising, promotional materials and nonpromotional materials in compliance with the applicable regulations and company policies....