Петро

GOLODIUK PETER

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Date of birth: 24/04/1982
Family status: married

SUMMARY
Currently employed as an expert, Registration/Renewal Materials (Quality Part) Expert Unit at Pharmaceutical Activity Department with the State Expert Center of the Ministry of Health of Ukraine. Has over 20 years of successful managerial experience in public and private health sector. Hold chemist diploma from the National Technical University of Ukraine "KPI" Faculty of Chemical Technology: Technology of Inorganic substances and General chemical technology.
KEY SKILLS:
• Experience in adaptation of international medical guidelines;
• Experience in Instrumental methods of analysis: GC, HPLC, IR, UV-VIS spectrophotometry, atomic absorption spectrometry, titration;
• Experience in development and validation of analitycal methods;
• Experience in SOP development and implementing;
• Experience in assessment of materials Module 3 registration dossier;
• Experience in Instrumental methods of analysis: HPLC, spectrophotometry, atomic absorption spectrometry, preparative chromatography (chromatographic systems: DanProcess, Kiloprep, K – prime);
• Experience in recovering of the hybrid protein; refolding; enzymatic hydrolysis refolded hybrid protein, followed by the formation of human insulin "raw"; purification and crystallization of human insulin;
• Experience in communication with international organizations;
• Experience in scientific engagement (self-sustained network of contact, scientific key opinion leaders);
• Commitment to high standards of work, strong work ethics, ambition and enthusiasm;
• Team leadership and management; learning on the fly; working under pressure, excellent in interpersonal/communication skills;
• Extremely organized, able to catch and correct even minor errors;
• Proficient in Microsoft Office, AutoCad, CorelDraw programs and others programs;
• Driving license “B” category.

PROFESSIONAL EXPERIENCE
The State Expert Center of the Ministry of Health of UkraineJanuary 2026 – August 2026

Position: Head of vaccines and blood and blood components (Quality Part) Expert Unit at Pharmaceutical Activity Department.
Scope of experience: Assessing of materials Module 3 registration dossier, supporting of registration and renewal procedures, quality assessment process management, support for the activities of the working groups; organization internal trainings, workshops, internal and external communication.

The State Expert Center of the Ministry of Health of UkraineApril 2022 – December 2025
Position: Head of the Quality Assessment Department for Renewal Dossiers, vaccines and blood and blood components.
Scope of experience: Assessing of materials Module 3 registration dossier, supporting of registration and renewal procedures, quality assessment process management, support for the activities of the working groups; organization internal trainings, workshops, internal and external communication.

The State Expert Center of the Ministry of Health of UkraineOctober 2016 – April 2022
Position: Expert, Registration/Renewal Materials (Quality Part) Expert Unit at Pharmaceutical Activity Department.
Scope of experience: Assessing of materials Module 3 registration dossier, supporting of registration and renewal procedures, quality assessment process menagment, support for the activities of the working groups; organization internal trainings, workshops, internal and external communication.

A focal point person WHO Collaborative registration procedure in Ukraine November 2015 – Present
Scope of experience: The collaborative registration procedure is a mechanism that promotes cooperation and information-sharing among regulators, to improve the efficiency of regulatory processes at a global level.
It also fosters the alignment of data-requirements and decisions in different regions of the world.
The procedure applies the concept of reliance to facilitate the assessment and approval of medicinal products by national authorities with limited regulatory resources.
National authorities can rely on a medicinal product evaluation already carried out by a recognised trusted regulatory authority, such as EMA, WHO to approve or refuse to authorise a medicinal product within its jurisdiction. The decision-making process is fully independent.
The use of reliance allows participating countries to reach a robust regulatory decision more quickly than otherwise possible, within 90 days.

The State Expert Center of the Ministry of Health of UkraineNovember 2014 – September 2016
Position: Deputy Director, Pharmaceutical Board.
Scope of experience: Assessing of materials Module 3 registration dossier, supporting of registration and renewal procedures, quality assessment process management, support for the activities of the working groups; SOP development and implementing; organization internal trainings, workshops, adoption of quality guidelines; internal and external communication.

Indian's Pharmaceutical Company Synmedic LTD, Ukraine September 2013 – October 2014
Position: Head of the Division of the registration, renewal, variations and certification department.
Scope of experience: Reviewing API and pharmaceutical processes for QA and validation requirements. To lead and train personnel on validation requirements. To implement and co-ordinate best practice procedures for validation activities and technology transfer to ensure compliance with cGMP. And regulatory requirements. Realization GMP Audits; filing of documents and SOPs; filing of all kinds of (CTD) documents; detailed and professional support with presubmission meetings; change Management & Variations.
The State Expert Center of the Ministry of Health of UkraineSeptember 2012 – September 2013
Position: Head of the Evidence of medicinal drugs and API renewal, Pharmaceutical Board Department.
Scope of experience: Spearhead all aspects of Drug Development and Regulatory Affairs including the design and execution of various types of registration.
November 2009 – August 2012
Position: Expert in procedures registration and renewal of medicines
Scope of experience: carrying out specialised expert evaluation of registration materials pertinent to medicinal product in order to prepare motivated conclusions and recommendations on making decision on possibility of its state registration, renewal, introduction of variations to the registration materials, or rejection in state registration, re-registration, introduction of changes to the registration materials for medicinal product.
To review assessment of materials Module 3 registration dossier, evaluation validation of analytical methods (protocols and reports), evaluation of analytical researches during pharmaceutical development.
The PrJSC “Indar”, manufacturing technology of human recombinant insulin of UkraineAugust 2007 – October 2009
Position: The manufacturing technology leader
Scope of experience: Development and validation of an ion-pair RP-HPLC method for the determination of Human Ihsulin. Pharmaceutical analysis, analytical chemistry, bioanalysis, quality control of pharmaceutical products, stability studies. Manufacturing technology of human recombinant insulin. Packing of chromatographic columns (column volume 30 – 100 l). Recovery of the hybrid protein; refolding; enzymatic hydrolysis refolded hybrid protein, followed by the formation of human insulin "raw"; purification and crystallization of human insulin. To lead and co-ordinate process and cleaning validation activities for the API and finished pharmaceutical manufacturing facilities. To keep up-to-date and access implications of changing validation requirements. To develop new analytical methods for use in Quality Control, In-Process Control and Process Technology. To improve exsting analytical methods, for example, to higher specificity and/or greater easy of operation. To validate new and existing analytical methods.
Quality control of medicines by instrumental methods of analysis (HPLC, GC, IR, UV-VIS spectrometry, etc); research activity in the fields of pharmaceutical analysis, conducting of stability studies; translation analytical documentation from English into Ukrainian.
The State Pharmacological Center of the Ministry of Health of Ukraine, the pharmaceutical DepartmentJuly 2005 – July 2007
Position: The leading Specialist
Scope of experience: assessment of materials Module 3 registration dossier, evaluation validation of analytical methods (protocols and reports), evaluation of analytical researches during pharmaceutical development.

National Laboratory for Quality Control of Drugs, Institute of Pharmacology and Toxicology UkraineApril 2004 – June 2005
Position: The leading Specialist
Scope of experience: quality control of medicines by instrumental methods of analysis (HPLC, GC, IR, UV-VIS spectrometry, etc); research activity in the fields of pharmaceutical analysis, conducting of stability studies; translation analytical documentation from English into Ukrainian.
EDUCATION
September 2004 – June 2006

National Technical University of Ukraine "KPI" Faculty of Chemical Technology: Technology of Inorganic substances and General chemical technology Master`s degree at Technology of Inorganic substances and General chemical technology
September 2000 – June 2004

National Technical University of Ukraine "KPI" Faculty of Chemical Technology: Technology of Inorganic substances and General chemical technology Bachelor`s degree at Technology of Inorganic substances and General chemical technology
LANGUAGES
Ukrainian, English –Upper intermediate
HOBBIES
Fishing, tourism, sport