ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
What You Will Do:
Your role will involve delivering regulatory affairs work to a high standard, working closely with your team and stakeholders.
Key responsibilities include:
- Manage activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), and any other central authorities for the assigned country/ countries.
- Perform submission and maintenance of new health records, renovations and modifications to keep the products on the market according to the strategic plan established by the company, current Colombian laws and current local health legislation in accordance with the corporate guidelines and policies, procedures and premises.
- Review of promotional materials for products for human use of their therapeutic line(s) in Veeva Vault or current tool.
- Perform submission and monitoring of products for human use of their therapeutic line(s) in procedures such as: PSUR, DSUR, RMPs, and safety information according to current Colombian regulations.
- Back-up to the Head of Regulatory Affairs and analysts of records in the procedures of INVIMA in order to guarantee the operation of the area.
- Ensure that IP labels are in adherence to country requirements and submitted where applicable.
- Support the senior level regulatory staff/country consultant in the maintenance of accurate, up-to date Country Knowledge repositor.
- Contribute to the maintenance and collection of regulatory intelligence by ensuring that tools such as the Country Knowledge Repository and the Country Fact Sheets are up-to-date and communicate new information or changes to the Regulatory Intelligence Consultant team.
- Preparation of el