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Хімік-аналітик

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Хімік-аналітик, Regulatory affairs manager
Вік:
33 роки
Місто:
Київ

Контактна інформація

Шукач вказав телефон та ел. пошту.

Прізвище, контакти та світлина доступні тільки для зареєстрованих роботодавців. Щоб отримати доступ до особистих даних кандидатів, увійдіть як роботодавець або зареєструйтеся.

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EXPERIENCE
Interchemie “De Adelaar” B.V.
Regulatory affairs officer | February 2023 - Present
- Compilation of registration dossiers for veterinary medicines (Modules 1-4, both in-
house and CTD formats) for new registrations and renewals in Asia, CIS and EU;
- Providing answers and justification on the questions from authorities during
national procedures and MRP;
- Responding to day-to-day queries and requests from regulators;
- Reviewing standard in-house and country-specific artworks for registration and
sales;

ANTON - Planning of regulatory procedures in cooperation with other departments;
- Planning, monitoring and control of all registration procedures; maintaining

SHOSTAK
records, updating internal electronic databases of veterinary medicines;
- Training of new employees;
- Monitoring the team's work and advising on the registration strategy;
- Revision of QA and QC documentation (SOP’s, specifications, methods of analysis,
method validation reports).

JSC Farmak
Senior chemist | May 2021 - February 2023
- Pharmaceutical development of new drug products (original and generics);
- Performing qualitative and quantitative analyses of raw materials, intermediates,
and finished products;
- Development and validation of analytical methods (HPLC, GC, AAS, UV-Vis);
- Development of analytical normative documentation, compilation of new drug
Skills in registration dossiers (Module 3).

JSC Arterium
Senior chemist | May 2020 - May 2021
• Compilation of registration - Workflow planning;
dossier; - Development of analytical normative documentation, compilstion of new drug
• Development of analytical registration dossiers (Module 3).
methods; Analytical chemist | Jun 2017 - May 2020
• Development of medicinal - Pharmaceutical development of new drug products (original and generics);
- Performing qualitative and quantitative analyses of raw materials, intermediates
products; and finished products;
• Preparing SDS - Development and validation of analytical methods (HPLC, GC, AAS, UV-Vis);
• Team management - Development of analytical normative documentation, completion of new drug
registration dossiers (Module 3).
State Scientific Research Laboratory for Medicines Quality Control
Analytical chemist | Mar 2016 - June 2017
- Performing qualitative and quantitative analyses of raw materials
intermediates and finished products;
- Participation in scientific research.

Languages
EDUCATION
English - upper-intrermediate Master degree National Technical University of Ukraine
Ukrainian - native in Ecology "Kyiv Polytechnic Institute"

2014-2016
Bachelor degree National Technical University of Ukraine
in Ecology "Kyiv Polytechnic Institute"

2010-2014

GENERAL INFORMATION
CONTACT INFORMATION Excellent problem-solving and time management skills;
Excellent communication, leadership, and project management skills;
Excellent computer skills;
Mobile: [відкрити контакти](див. вище в блоці «контактна інформація»)
Ability to work independently and in a team environment;
Email: [відкрити контакти](див. вище в блоці «контактна інформація») Personal qualities: passion for work, responsibility, fast learning ability, self-
LinkedIn: [відкрити контакти](див. вище в блоці «контактна інформація») motivated, aware of own strenghts and weaknesses.
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