Latam Regulatory Affairs Coordinator
hace 1 semana
**Role description**
- Coordinate the Regulatory Affairs activities at the export markets (Ecuador, Peru, Venezuela, Bolivia, Paraguay and Uruguay)
- Implement and execute Regulatory Affairs processes and policies ensuring that all the aspects of the product safety are closely monitored and fulfil the regulatory requirements through ongoing support and solutions
- Contribute to developing regulatory activities on both new and in-line products in accordance with health authorities to define registration plans to meet business needs.
- Track the alignment of the Regulatory Affairs activities like preparation, submission and follow-up of medical affairs, authorities (MAA) and registration files and reconcile any deviation from plans and processes
- Implement, execute, and maintain the programs and policies ensuring the organization is aware of and compliant with legislation and regulations pertaining to the business
- Contribute to the development and administration of all processes related to Regulatory Affairs Generalists programs and policies, monitoring/interpreting regulatory developments and determining the impact on business operations and compliance programs
- Collaborate with other teams of Regulatory Affairs on compliance implementation, regulatory reporting/documentation for internal and external audiences; to support all stakeholders
- Participate in driving transformation and change by gathering data, preparing, reviewing, and/or approving regulatory compliance documents to maximize effectiveness and efficiency
-
Regulatory Affairs Specialist, Latam
hace 1 semana
Bogota, Colombia Novasyte A tiempo completoPOSITION TITLE: Regulatory Affairs Specialist REPORTS TO: Manager, Regulatory Affairs or Designee BASIC FUNCTIONS: ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: - Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory information, guidance,...
-
Regulatory Affairs Manager
hace 4 días
Bogota, Colombia Johnson & Johnson Family of Companies A tiempo completoRegulatory Affairs Manager - LA North Cluster At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion...
-
Regulatory Affairs Lead
hace 4 días
Bogota, Colombia Takeda Pharmaceutical A tiempo completo**Regulatory Affairs Lead** **WHAT YOU WILL DO** The role exists to lead 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...
-
Regulatory Affairs Specialist
hace 1 semana
Bogota, Colombia Zimmer Biomet A tiempo completo**Requisition Number**: AMER27699 **Employment Type**: Full-time **Location**: Bogota **Job Summary**: Responsible for assisting the team with regulatory change assessments and filings as necessary to market and maintain Zimmer Biomet products. This position requires an intermediate understanding of medical devices and their use as well as a understanding...
-
Regulatory Affairs Coordinator
hace 2 semanas
Bogota, Colombia Johnson & Johnson A tiempo completoAt Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for...
-
Regulatory Affairs Manager
hace 1 semana
Bogota, Colombia Lilly A tiempo completoAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...
-
Regulatory Affairs Coordinator
hace 3 días
Bogota, Colombia Johnson & Johnson A tiempo completoAt Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for...
-
Bogota, Colombia Johnson & Johnson A tiempo completoAt Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130...
-
Regulatory Affairs Specialist
hace 19 horas
Bogota, Colombia Zimmer Biomet A tiempo completoAt Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life...
-
Regulatory Affairs Associate
hace 6 días
Bogota, Colombia Eli Lilly A tiempo completoAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...
