Profile

Maxim Mikhalevitch

Maxim Mikhalevitch obtained his Master of Science (MSc) in Pharmacy from Pharmaceutical Academy, St Petersburg in 1991. In 1994, he was graduated as MSc in Pharmacy in the Netherlands (BIG register number 69048324117). In 2004, he finished Regulatory Affairs School led by Prof. Dr. H.G.M. Bert Leufkens at SIR Pharma Policy Institute in Leiden and obtained the diploma of Expert in Regulatory Affairs. In 2015, he graduated as Master of Science in Regulatory Affairs from University of Wales in the UK (Validated by TOPRA).

Maxim has more than 25 years work experience in the pharmaceutical industry.

In 1995, he started his career as a QA Project manager at Pharmachemie BV (Part of Teva) in the Netherlands, executing a compliance related project and remediation CAPAs.

In 1997, he started as a production pharmacist at the Parenteral department of Pharmachemie BV, having the responsibility for the organisation of production processes, creating and review of batch documentation, troubleshooting and training of operators in aseptical operations.

In 2001, he switched to the Regulatory Affairs department of Teva-Pharmachemie BV and spent more than 10 years in the role of Sr RA Manager, supporting cross-functional R&D teams in developing RA strategies and building Module 3 of the eCTD, and managing a team of RA professionals.

In 2011, he started as Associated Director QA Business Development at Teva Pharma BV, leading a team of (Sr) QA professionals and having the responsibility for GMP due diligence on CM(D)Os selected for development and/or supply products to Teva. In this role, he also became a Qualified Person (QP), having among others the responsibility for decision making on the GMP acceptance of CM(D)Os for Teva and signing QP GMP compliance declarations for APIs and intermediates in conformity with EMA/334808/2014.

In 2014, Maxim joined Management Team of Quality Assurance Department of Teva-Pharmachemie BV in the role of Associate Director QA R&D/QP, leading a team of Senior QA professionals and having the responsibility to support in GMP compliance two R&D Departments – Respiratory and Generic. Main activities were analytical and pharmaceutical (formulation) development, validation of analytical methods, scale-up and tech transfers, manufacturing process qualification and validation, building of registration dossiers (CMC) and Pharmaceutical Quality Systems for Investigational Medicinal Products.

In May 2019, Maxim left Teva and founded PMC.