Regulatory Affairs Specialist

hace 3 semanas

San Vicente Ferrer, Colombia Takeda Pharmaceutical A tiempo completo

English version_

**WHAT YOU WILL DO**

The position is accountable of support the business strategic plan to obtain Marketing Authorizations, renewals, and variations, both for existing and new products and coordinate Regulatory Excellence activities in Colombia ensuring compliance to company Global Regulatory requirements (processes & tools) and to local Country Regulations in liaison with all the concerned areas. Responsible for acting in compliance with country policies and practices to reduce company’s exposure to regulatory risks. Participate actively in designated projects, as well as in committees and meetings with government agencies when necessary.

This position reports to Regulatory Affairs Head and is based in Bogotá, Colombia.

**WHAT YOU WILL WORK ON**
- Support the submission of pharmacological, technical, and legal dossiers for Marketing Authorizations, renewals, as well as Marketing Authorizations amendments for products in the portfolio and for new products.
- Provide support to prepare regulatory responses to resolve agency questions on time.
- Lead the process to maintain clinical urgencies submissions (NPPs).
- Execute the MA renewal planning.
- Maintain follow up with the local Health Authorities to obtain the approvals according with the RA planning.
- Complete on time the assigned trainings.
- Review and approve local labelling material.
- Support (if required) creation of LCRs and RFM requests.
- Evaluate CCDS changes and submit at local level according with corporate timelines.
- Keep on track regulatory submissions, and define strategies to comply with expected approval dates.
- Artwork review and approval.
- Promotional and non-promotional materials review and approval.
- Attend meetings with Health Authorities.
- Enhance the operational performance and quality output through continuous process improvement.
- Identify, align, and implement risk mitigation strategies for all regulatory processes.
- Perform regulatory intelligence strategy for Colombia by monitoring of regulatory status for competitors and monitoring, assessing impact and scaling up of new regulations.
- Ensure regulatory systems and databases are timely maintained and perform the Monthly Reports.
- Maintain the local RA SOPs updated according with the new regulations.
- Coordination of Trainings for Newcomers.
- Support on audits & follow up on CAPAs.
- Compliance of internal policies.

**WHO ARE WE LOOKING FOR**

**Experience & Education**
- Bachelor’s degree preferably of Pharmacist.
- Solid knowledge of drug products (small molecules and biologics) and medical devices regulations in Colombia.
- Minimum 5 years’ experience in Regulatory Affairs, focus biological and biotechnological products.
- Advanced-level English.

**Competences & Skills**
- Strategic thinking.
- Multidisciplinary team working experience.
- Teamwork and communication.
- Focused on the customer.
- Management problem solving skills.
- Business acumen.
- Research and good teamwork skills.
- Results oriented.
- Committed to foster a diversity, equity, and inclusive environment.

**LOCATION**:Bogotá, Colombia.
- Versión Español_

**PROPOSITO DEL ROL**

Este rol es responsable de apoyar el plan estratégico del negocio para obtener autorizaciones de comercialización (Registros Sanitarios), renovaciones y variaciones, tanto para productos existentes como nuevos y coordinar las actividades de Excelencia Regulatoria en Colombia asegurando el cumplimiento de los requisitos regulatorios globales de la compañía (procesos y herramientas) y las regulaciones locales del país en coordinación con todas las áreas interesadas. Es también responsable de actuar de conformidad con las políticas y prácticas del país para reducir la exposición de la empresa a los riesgos regulatorios. Asimismo, participa activamente en proyectos designados, así como en comités y reuniones con agencias gubernamentales cuando sea necesario.

La posición reporta al Regulatory Affairs Head y está basada en Bogotá, Colombia.

**DESAFIOS EN LA POSICIÓN**
- Apoyar la presentación de expedientes para evaluación farmacológica, expedientes técnicos y legales para la aprobación de Registros Sanitarios, renovaciones, así como modificaciones de Registros Sanitarios para productos en comercialización y para nuevos productos.
- Preparar respuestas regulatorias para resolver las preguntas de la Autoridad Sanitaria a tiempo.
- Liderar el proceso para mantener las presentaciones de urgencias clínicas (NPP).
- Ejecutar la planificación de las renovaciones de los Registros Sanitarios.
- Mantener el seguimiento con la Autoridad Sanitaria local para obtener las aprobaciones de acuerdo con la planificación de Asuntos Regulatorios.
- Completar a tiempo los entrenamientos asignados.
- Revisar y aprobar la Información para prescribir e insertos locales.
- Soporte (si es necesario) para la creación de LCRs y solicitudes RFM.
- Evaluar los cambios de CCDS y realizar los

  • Regulatory Affairs Coordinator

    hace 4 semanas

    San Vicente Ferrer, Colombia Galderma A tiempo completo

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...

  • Senior Regulatory Affairs Specialist

    hace 2 semanas

    Municipio de San Vicente Ferrer, Colombia Essity A tiempo completo

    [Job Title]:Senior Regulatory Affairs SpecialistAbout the Role:Asegurar que el surtido de productos asignado dentro de su área regulada esté documentado y procesado de acuerdo con los procesos y procedimientos regulatorios y de calidad internos con el fin de obtener y mantener la autorización de mercado a nível internacional. El rol también es...

  • Clinical Specialist, Oral Care Solutions Division

    hace 3 semanas

    San Vicente Ferrer, Colombia 3M A tiempo completo

    **Job Description**: Clinical Specialist, Oral Care Solutions Division - Cali Colabora con 3Mers innovadores alrededor del mundo Como Clinical Specialist desempeñarás un rol clave en la implementación de la estrategia educativa en la división de Soluciones de Cuidado Oral para la región andina. En este rol podrás, contribuir a la educación de los...

  • Quality Assurance and Regulatory Affairs

    hace 2 semanas

    San Vicente Ferrer, Colombia G SAS A tiempo completo

    _LABORATORIO FARMACÉUTICO Importador de medicamentos de alto costo se encuentra en búsqueda de profesional _**Químico Farmacéutico**_ _o cursando últimos semestres; con Conocimientos en Asuntos regulatorios a nível LATAM y Centroamérica, Aseguramiento de calidad, BPM e INVIMA en el sector farmacéutico._ Indispensable contar con: - Inglés...

  • Sr Site Activation Specialist

    hace 4 semanas

    San Vicente Ferrer, Colombia Syneos Health Clinical A tiempo completo

    **Description** **Senior Site Activation Specialist** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to...

  • Clinical Operations Manager

    hace 4 semanas

    San Vicente Ferrer, Colombia MSD A tiempo completo

    This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Head COMs or, the person is responsible for execution and...

  • Quality Assurance and Regulatory Affairs

    hace 2 semanas

    Municipio de San Vicente Ferrer, Colombia G SAS A tiempo completo

    _LABORATORIO FARMACÉUTICO Importador de medicamentos de alto costo se encuentra en búsqueda de profesional _Químico Farmacéutico_ _o cursando últimos semestres; con Conocimientos en Asuntos regulatorios a nível LATAM y Centroamérica, Aseguramiento de calidad, BPM e INVIMA en el sector farmacéutico._Indispensable contar con: Inglés técnico...

  • Clinical Specialist, Oral Care Solutions Division

    hace 2 semanas

    Municipio de San Vicente Ferrer, Colombia 3M A tiempo completo

    Job Description:Clinical Specialist, Oral Care Solutions Division - CaliColabora con 3Mers innovadores alrededor del mundoComo Clinical Specialist desempeñarás un rol clave en la implementación de la estrategia educativa en la división de Soluciones de Cuidado Oral para la región andina. En este rol podrás, contribuir a la educación de los...

  • Food Security Specialist

    hace 4 semanas

    San Vicente Ferrer, Colombia Amentum A tiempo completo

    The purpose of this effort is to support Amentum Macfadden to position to provide professional oversight and training for all RDAP emergency food assistance and/or food security and nutrition activities for the U.S. Agency for International Development (USAID), Bureau for Humanitarian Affairs (BHA) Regional Disaster Assistance Program (RDAP) in the Latin...

  • S&op Specialist

    hace 3 semanas

    San Vicente Ferrer, Colombia Abbott Laboratories A tiempo completo

    : Supply Planning for ARDx's Argentina and Colombia markets to track core customer orders Responsible for the Order Escalation and Order Fulfillment Process Responsible for the management of Turn Around Time at S&OP (from order confirmation to availability for pickup) Responsible for supporting the Collaborative Planning Process with Key Distributors NPI &...

  • Senior Associate, Infrastructure Specialist

    hace 1 semana

    San Vicente Ferrer, Colombia Kyndryl A tiempo completo

    Who We Are Kyndryl is a market leader that thinks and acts like a start-up. We design, build, manage, and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward - always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our...

  • Clinical Operations Manager

    hace 2 semanas

    Municipio de San Vicente Ferrer, Colombia MSD A tiempo completo

    This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally.Under the oversight of the Head COMs or, the person is responsible for execution and oversight...

  • S&op Specialist

    hace 2 semanas

    Municipio de San Vicente Ferrer, Colombia Abbott Laboratories A tiempo completo

    :Supply Planning for ARDx's Argentina and Colombia markets to track core customer ordersResponsible for the Order Escalation and Order Fulfillment ProcessResponsible for the management of Turn Around Time at S&OP (from order confirmation to availability for pickup)Responsible for supporting the Collaborative Planning Process with Key DistributorsNPI & SKU...

  • Consultant, Strategic Communications, Latam

    hace 5 días

    San Vicente Ferrer, Colombia FTI Consulting, Inc. A tiempo completo

    **About Strategic Communications** The Strategic Communications segment of FTI Consulting is one of the world's most highly regarded communications consultancies with a 30-year track record of designing and executing communications strategies for clients managing financial, regulatory and reputational challenges. The Strategic Communications segment serves...

  • Consultor Principal en Sostenibilidad Corporativa y

    hace 2 semanas

    San Vicente Ferrer, Colombia ERM Group A tiempo completo

    As part of the continued growth and innovation of our Corporate Sustainability & Climate Change service area, ERM has an opportunity for an experienced leader to join our global consulting firm as a Principal Consultant in Colombia and become a true owner and shareholder in a business with Sustainability at its heart. ERM is a fast growing global management...

  • Consultor Principal en Sostenibilidad Corporativa y

    hace 2 semanas

    Municipio de San Vicente Ferrer, Colombia ERM Group A tiempo completo

    As part of the continued growth and innovation of our Corporate Sustainability & Climate Change service area, ERM has an opportunity for an experienced leader to join our global consulting firm as a Principal Consultant in Colombia and become a true owner and shareholder in a business with Sustainability at its heart.ERM is a fast growing global management...

  • Especialista - Seguridad

    hace 2 semanas

    San Marcos, Sucre, Colombia Kontoor Brands A tiempo completo

    Job Description The EH&S Specialist is responsible for driving the safety culture by providing information and advice to plant management on matters relating to safe operations. Extensive time is spent on the production floor to build effective relationships, conduct job safety observations and to be involved in decisions that affect the safety of our...