Mrs Luba Skibo
Executive Director
M.S. Agricultural Chemistry, M.S. Analytical Chemistry
- [email protected]
- + 1 857 277 0060
Luba is a chemist with M.S. degree in agricultural chemistry from the Moscow University and M.S. degree from CUNY in analytical chemistry, Luba has over 20 years’ experience in the pharmaceutical industry and over 13 years of Regulatory Affairs experience. She worked for Pfizer, Inc., in a series of progressive positions in Quality Control, CMC and Regulatory Affairs areas where she had an extensive hands-on experience with global CMC filings for new product and post-approval changes.
In her role as the Director of Regulatory Affairs for Merial Limited Pharmaceuticals responsible for the approved products portfolio and most recently as a Head of WW Regulatory Operations, Luba was heavily involved in geographical extension to the Emerging Markets.
Luba has extensive knowledge of US, EU and global regulations as well as global GMP and GLP requirements for IMPs and approved products. An area of particular interest, enthusiasm, and expertise is penetration to Emerging markets including navigation of regulatory framework, training on cultural sensitivities and planning of product logistics.