Контактная информация

Соискатель указал телефон и LinkedIn.

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Опыт работы

Associate Director Regulatory Affairs CIS

с 06.2023 по 03.2026 (2 года 10 месяцев)
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

с 08.2015 по 05.2023 (7 лет 10 месяцев)
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

с 06.2012 по 08.2015 (3 года 3 месяца)
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

Образование

Національний медичний університет імені О.О.Богомольця

Фармація, Київ
Высшее, с 2005 по 2010 (5 лет)

Знания и навыки

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

Знание языков

• Украинский — свободно
• Английский — выше среднего