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
