Peru_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.

Assist in the implementation and maintenance of the Quality Management System, reviewing standard operating procedures related to Good Storage, Transportation, and Distribution Practices, and verifying compliance with the Quality Manual in routine activities. Coordinate with logistics operators to supply technical documents related to the portfolio. Collect regulatory information from the health authority's website to prepare information such as reports, health registration validity, and tracking of company regulatory procedures. Organize documentation and manage payment orders for health registration procedures (new, renewals, modifications). Prepares drafts for IPS reports and consultations with the health authority related to pharmacovigilance. Compiles Pharmacovigilance activity implementation needs and prepares preliminary reports.