PharmaLex Group expands regulatory footprint

Laura Monkiene

The appointment of Laura Monkiene, will enhances the Regulatory Outsourcing Team, according to PharmaLex.

PharmaLex Group, one of the largest providers for Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance worldwide, has enhanced its Regulatory Outsourcing Team with the addition of Laura Monkiene.

Laura Monkiene joins PharmaLex as Director/Principal Consultant. With her extensive experience, she will lead local and global projects and support clients worldwide with regulatory affairs, medical writing and pharmacovigilance service demands.

Monkiene brings a great knowledge base and has a clear understanding of the global, specifically Russia and CIS regulatory landscape.

Her responsibilities will include management of new and strategically important projects, communication with regulatory agencies and management of local PharmaLex representatives in the CIS region.

“The CIS region is a growing and important market and we are building on Laura’s management capabilities to increase our local presence and team. We are excited to welcome Laura to the PharmaLex Group,” explained Dr Kirsten Jacobs, Executive VP Regulatory Affairs.

Monkiene added: “The CIS region is undergoing major changes in the regulatory framework related to the Eurasian Economic Union (EAEU) regulations. Exceptional focus should be given to new process´ implementation and re-registrations of current portfolios before 31 December 2025. By strengthening our presence in the region we aim to support our customers to navigate through the changes as early and as comfortable as possible.”

Monkiene has a Masters Degree in Pharmacy from the Lithuanian University of Health Sciences and a second Masters Degree in Business Economics from Kaunas University of Technology.

The PharmaLex Group now has more than 700 employees, with 26 offices in 14 countries and more than 600 clients worldwide.

Companies