20 publicaciones de empleo destacadas de regulatory coordinator en ciudad de méxico (¡Están contratando!)

Regulatory Affairs Coordinator
AbbVie —Ciudad de México, CDMX
- Tiempo completo
- Trabajo híbrido
- Inglés
- Licenciatura
4d
Sr. People Operations Coordinator
DocuSign —Ciudad de México, CDMX
- Microsoft Excel
- Inglés
- Licenciatura
1d
Responsable de Suministros y Materiales Operativos, Environmental Assurance and Protection (EAP)
Servicios Comerciales Amazon México S. de R.L. de C.V. —Cuauhtémoc, CDMX
- $15,687.50 por mes
- Incluye fines de semana
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
Remote Executive Assistant, Operations & Compliance Support (LATAM)
FreedUp —Ciudad de México, CDMX
- Tiempo completo
- Home Office (Desde casa)
- Administración de personal
- Mantenimiento
- Licenciatura
- Vacaciones adicionales o permisos con goce de sueldo
Postulación rápida
Project Coordinator I
Fortrea —Ciudad de México, CDMX
- Tiempo completo
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
SFE Coordinator
Haleon —Ciudad de México, CDMX
- Tiempo completo
- Microsoft Excel
- Análisis de datos
- Inglés
- Oportunidades de crecimiento
HSE BU Continuous Improvement Coordinator
Mondelēz International —Colonia Santa Fe, CDMX
- Tiempo completo
- Permiso de maternidad y paternidad
BU Health Coordinator
Mondelēz International —Colonia Santa Fe, CDMX
- Tiempo completo
- Administración de personal
- Experiencia en manufactura
- Permiso de maternidad y paternidad
Corporate Finance Sr Coordinator
Viva —Ciudad de México, CDMX
- Trabajo híbrido
- Administración de personal
- Inglés
- Licenciatura
- Vacaciones adicionales o permisos con goce de sueldo
Consultant for the Regulatory Diagnosis and Analysis of HFC-23 Policies
The United Nations Industrial Development Organization (UNIDO) —Ciudad de México, CDMX
- Administración de personal
- Inglés
- Maestría
11d
Regional Director for Mesoamerica
Just Associates Inc —Del Valle Centro, CDMX
- Bilingüe
- Administración de personal
- Inglés
Postulación rápida
2d
National Project Expert - HCFC Phase-out Management Plan
The United Nations Industrial Development Organization (UNIDO) —Ciudad de México, CDMX
- Administración de personal
- Inglés
- Maestría
9d
HSE Coordinator Merchandisers
Mondelēz International —Colonia Santa Fe, CDMX
- Tiempo completo
- Permiso de maternidad y paternidad
Customer Marketing Coordinator
Haleon —Ciudad de México, CDMX
- Tiempo completo
- Microsoft Excel
- Mercadotecnia
- Inglés
Intersectional Pharmacist for International Humanitarian Missions
Médicos Sin Fronteras en México A.C [Proyectos internacionales] —Ciudad de México, CDMX
- $2,000 por mes
- Tiempo completo
- Administración de personal
- Hospital
- Inglés
- Seguro de vida
Billing Coordinator
Tradewin —Ciudad de México, CDMX
- Tiempo completo
- Microsoft Word
- Microsoft Excel
- Servicio al cliente
- Plan de adquisición de acciones empresariales
- Seguro de vida
Postulación rápida
Multinational Specialist
AIG MEXICO SERVICIOS S.A. DE C.V. —Ciudad de México, CDMX
- Correo electrónico
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Seguro de vida
Postulación rápida
9d
Especialista Infraestructura
AIRBUS HELICOPTERS MEXICO, S.A. de C.V. —Ciudad de México
- Tiempo completo
- Administración de personal
- Gestión de inventario
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Regional Market and Product Expansion Manager - Vice President
JPMorganChase —Colonia Lomas de Chapultepec, CDMX
- Tiempo completo
- Administración de personal
- Licenciatura
- Gestión de productos
Digital & IM Delivery Supervisor
Harbour Energy —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Licenciatura
1d

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Regulatory Affairs Coordinator

AbbVie -
Ciudad de México, CDMX

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Información del empleo

Tiempo completo
Hace 4 días

Cualificaciones

Inglés
Licenciatura
Farmacia

Descripción completa del empleo

Company Description

About AbbVie

AbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Purpose

Coordinate all the required activities with Area Therapeutic Area Teams and local stakeholders to ensure that the dossier content complies with local regulations to submit to the local Health Authority the required applications in order to obtain the marketing authorization for new products or the required variations or renewal.
Coordinate all the required activities for label update based on reference label to submit to the local Health Authority according to KPIs timelines.
Execute the review and approval process of advertising, promotional and non-promotional materials in compliance with the applicable regulations and company policies.
Coordinate all the required activities with Area Therapeutic Area Teams to ensure the availability GMPc issued by the local Health Authority for the applicable products/manufacturing sites.
Control and guard of GMPs, CPPs, PoAs, LoAs, and other legal documents

ADVERTISING Prepare the advertising application files for Cofepris submission and coordinate the submission dates with MKT.
Update global regulatory systems in compliance with the timelines defined.

Responsibilities

Review and validate the translation to Spanish of documents translated by Area and local translations.
Coordinate the translation to Spanish of the technical, legal and/or clinical support documentation provided by global.
Prepare, review and integrate the files for the submission to the local Health Authority.
Ensure the dossier meets with the local requirements according to the corresponding regulations
Execution of the activities required for the Subcommittee of Evaluation of Biotechnology Products & New Molecules Committee presentation.
Give a close follow up to internal activities needed for the review & approval of administrative & technical variations.
Develop the local labeling texts ensuring that they meet with local regulations, internal SOP and the reference document provided by AREA.
Drive labeling process for creating new or updating previous artworks for the pharmaceutical, biotechnological & biological products, as initiator and/or reviewer.
Ensure that the GMPs and other legal regulatory documents of manufacturing sites are valid during the entire lifecycle of the marketing authorization. Applicable for documents issued by the local Health Authority or other regulatory agencies.
Maintain the archive of the GMPs, CPPs, PoAs, LoAs, and other legal documents and maintain the control of the documents ensuring that the originals are kept and ensure there is always available at least one certified copy of each document[SCAL1] and request new certified copies to the Administrative Assistant.
Keep updated the tracking database and due dates for the request of the GMPs, CPPs, PoAs, LoAs, and other legal documents to the GSSC.[SCAL2]
Review of advertising and promotional material in Veeva and submission to Cofepris.
Prepare, submit and obtain the approval for local biological product release.
Participate in the assigned meetings internally and externally.
Execute all the activities described in alignment with AbbVie culture and philosophy.
Keep updated the applicable SOP.
Keep updated the global regulatory systems.

Position Accountability / Scope

Maintain budget control.

Internal areas of interaction: Sanitary responsible, Quality Assurance, Marketing, Medical, Pharmacovigilance, Demand, Market Access, AREA Regulatory, this list is enunciative and not limitative, any other interaction area required may be included in the scope.

External Areas:

Mexican National Regulatory Agency (COFEPRIS), industry associations (CANIFARMA, AMIIF) and A&AS Area (Area and Affiliate Support)

Qualifications

Qualifications

Education Requirements: Bachelor degree. Pharmacist, Biotechnology Engineer, Pharmaceutical Engineer or related demonstrable professional degree.
2 to 5 years in a similar position.
Knowledge in Health regulation in Mexico.
Good communication skills.
Good relationships with internal stakeholders.
Continuous tracking of self and other activities.
Fluent in English written and spoken.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

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regulatory coordinator empleos en ciudad de méxico

Regulatory Affairs Coordinator

Sr. People Operations Coordinator

Responsable de Suministros y Materiales Operativos, Environmental Assurance and Protection (EAP)

Remote Executive Assistant, Operations & Compliance Support (LATAM)

Project Coordinator I

SFE Coordinator

HSE BU Continuous Improvement Coordinator

BU Health Coordinator

Corporate Finance Sr Coordinator

Consultant for the Regulatory Diagnosis and Analysis of HFC-23 Policies

Regional Director for Mesoamerica

National Project Expert - HCFC Phase-out Management Plan

HSE Coordinator Merchandisers

Customer Marketing Coordinator

Intersectional Pharmacist for International Humanitarian Missions

Billing Coordinator

Multinational Specialist

Especialista Infraestructura

Regional Market and Product Expansion Manager - Vice President

Digital & IM Delivery Supervisor

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