Karina Rebild is M.Sc. Pharmcy and has been with Billev Pharma since August 2020. Karina now holds the position as Regulatory Affairs Manager.
Karina has 12 years of Regulatory CMC experience from a Global Danish Pharmaceutical Company where she managed Regulatory CMC tasks as lifecycle management and Regulatory Affairs CMC matters for Clinical Trial Applications.
- - Variations, line extensions and renewals.
- - Initial marketing authorisation applications for mature products to new markets.
- - Quality IMPDs and IND Quality overall Summary and Module 3 documents along with other regulatory CMC issues.
- - Procedures: CP, DCP, MRP, national submission.