Contact information

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Work experience

Associate Director Regulatory Affairs CIS

from 06.2023 to 03.2026 (2 years 10 months)
MSD Ukraine, Київ (Медицина, охорона здоров'я, аптеки)

• Planning, support, and control of registration activities: registration, renewal and all types of variations in CIS countries: Belarus, Armenia, Azerbaijan, Afghanistan, Georgia, Moldova, Uzbekistan, Turkmenistan, Tajikistan, Kyrgyzstan, Mongolia for the medicinal products of the Company within strategies and plans according to global and local policies
• Support effective registration of pipeline products & lifecycle management
• Support of supply and distribution agreement between MSD and TPP in CIS countries in frame of Regulatory area.
• Cross-collaboration work with internal and external stakeholders for prevention of stock out and coordination of new launches.
• People management, including personal development & motivation
• Ensure continued internal audit & HA inspection readiness
• Ensure alignment of local regulatory aspects with global processes
• Digital Transformation: ensure implementation of new tools in our processes
• Support the document lifecycle with CIS vendors
• Development and timely review of local SOPs and procedures in accordance with global policies and procedures
• Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization, and other stakeholders
• Participates in internal registration managers' meetings at sub-regional and regional level and other cross functional meetings to provide regulatory input and expertise
• Preparing accurate monthly/bi-weekly reports on regulatory statuses for business partners/HH partner/upper management
• Acting as QRP

Manager, Regulatory Affairs CIS MSD Ukraine

from 08.2015 to 05.2023 (7 years 10 months)
MSD Ukraine, Київ (Медицина, охорона здоров'я, аптеки)

•Planning, support, and control of registration activities: registration, renewal and all types of variations in CIS countries: Belarus, Armenia, Azerbaijan, Afghanistan, Georgia, Moldova, Uzbekistan, Turkmenistan, Tajikistan, Kyrgyzstan, Mongolia for the medicinal products of the Company within strategies and plans according to global and local policies
• Support effective registration of pipeline products & lifecycle management
• Support of supply and distribution agreement between MSD and TPP in CIS countries in frame of Regulatory area.
• Cross-collaboration work with internal and external stakeholders for prevention of stock out and coordination of new launches.
• People management, including personal development & motivation
• Ensure continued internal audit & HA inspection readiness
• Ensure alignment of local regulatory aspects with global processes
• Digital Transformation: ensure implementation of new tools in our processes
• Support the document lifecycle with CIS vendors

Senior Specialist, Regulatory Affairs CIS MSD Ukraine

from 06.2012 to 08.2015 (3 years 3 months)
MSD Ukraine, Київ (Медицина, охорона здоров'я, аптеки)

• Right and well-timed creation and implementation of artworks according CIS regulatory activities
• Support product life-cycle management in CIS countries: Belarus, Armenia, Azerbaijan, Afghanistan, Georgia, Moldova, Uzbekistan,
Turkmenistan, Tajikistan, Kyrgyzstan, Mongolia for the medicinal products of the Company within strategies and plans according to global and local policies
• Cross-functional work with logistic, marketing departments and HUB
• Correct and well-timed filling out and updating ORION date base
• Coordination of creation new production codes with packaging sites and HUB

Education

Національний медичний університет імені О.О.Богомольця

Фармація, Київ
Higher, from 2005 to 2010 (5 years)

Knowledge and skills

• Комунікабельність
• Управління персоналом
• Уміння аналізувати
• Управлінські навички
• Водійські права кат. B
• Самостійне прийняття рішень

Language proficiencies

• Ukrainian — fluent
• English — above average