Regulatory Affairs Manager

Over 20 years of hands-on experience in creating, updating, and managing Module 3 documentation for submissions, variations, and renewals across EU and CIS region

In-depth regulatory work with chemical, oncological, and herbal medicines – directly aligning with the project’s product focus

Fluent in English and Russian, with deep experience in EU and CIS regulatory frameworks – ideal for international submissions and collaboration

Highly skilled in Gap analysis, Change Control, and responding to deficiency letters based on source documents from manufacturing and QC – hands-on execution, not just consulting

Writing, Compilation and management of registration documents (Common Technical Document Modules 1,2,3,4,5) according EU legislation for Germany and Europe

Renewals / Variation / handling of deficiency letters / change management

Medical writing of product information (PL, SmPC, Label)

Support of third party clients

Writing, Compilation and management of registration documents (Common Technical Document Modules 1,3,4,5 and Normative Documentation in Russian language) according national rules for submission of new products in CIS

Renewals / handling of deficiency letters / change management

Support representative offices in CIS

Medical Writing of PIL, SPC and Label (English, German, Russian)

Writing of finished products specification in Russian language

Writing, Compilation and management of registration documents (Part II/Part I NtA respectively Module 3 /2.3 Common Technical Document) according EU legislation for Germany and Europe

Renewals / posteriori registrations / Variation / handling of deficiency letters

Change management

Support of third party clients