Regulatory Affairs Specialist
ICON • Bogotá, Colombia
Role Description
Regulatory Affairs - office based - Bogota
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 l...