Chile Regulatory Intern

Celltrion Group provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world.

Celltrion Group offers biologics to about 110 countries, along with more than 30 global partners around the world. With hands-on experience and knowledge accumulated through years of working in the advanced pharmaceutical markets around the world, Celltrion Group has been securing distribution channels and providing patients with biosimilars at affordable prices.

1. Implementation and improvements to the quality system, with a focus on the pharmacovigilance system.

2. Review of Standard Operating Procedures (SOPs) to address the corporate audit, including the CAPA analysis from the previous audit.

3. Support for regulatory affairs tasks, import procedures, regulatory modifications, and applications submitted through the ISP platform.

4. Support for pharmacovigilance tasks such as the preparation of Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs).