Celltrion Group provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world
Job Summary
Celltrion Group provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world.
In charge of regulatory affairs and quality assurance work corresponding to the product life cycle of biopharmaceuticals, including application work for individual projects.
Responsibilities include pharmaceutical applications, authority correspondence, CTD/FD document creation, new product introduction support, regulatory consultation, CMC support, and manufacturer coordination.
Matching Summary
Celltrion Group provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world.
Skills & Requirements
Must-have
Pharmaceutical applications for drugs
CTD and FD application documents
Regulatory consultation work
CMC regulatory support
Negotiate and coordinate with manufacturers
Nice-to-have
Increase patient access to advanced therapies
Global partners around the world
Affordable prices
Key Requirements
Years of experience in advanced pharmaceutical markets
Regulatory affairs and quality assurance experience