Работала в 5 компаниях 12 лет 7 месяцев
Фармацевтика
Business Development Manager
Bioscience Ukraine LLC, Kyiv
Фармацевтика
9 месяцев
04.2024 - 01.2025
- Researching market in order to acquire new clients and turn this into increased business
- Developing partnerships with other companies to drive growth, improve efficiency, and bring new products to market
- Arranging business development meetings with prospective clients
- Coodination the progress of signing CDA, LSA, SDEA
- Coordination of possible business models with partners (License-in, Distribution agreement)
- Organization of the dossier audit
- Сoordination with manufacturers at all stages of projects
- Supporting other Departments in contacting business partners
- Provision of reliable data according to the partners request
International Regulatory Affairs
ACINO Україна
Фармацевтика
3 года 4 месяца
08.2020 - 12.2023
- Analysis of materials for compliance with regulatory requirements
- Coordination the deadlines for preparation and submission registration dossiers according to requirements of relevant country
- Support regulatory submissions,е-CTD submissions (new registrations and life cycle management) of Acino portfolio products in countries and markets within the assigned international region(s) under supervision of Manager/GRA Lead (Regions of focus: Mena, Latam, Africa, Switzerland)
- Support to partners in the region(s) in regards of preparations of responses to DLs and supporting additional materials
- Handling and coordination of legalization processes for RA documents, etc
- Active support to Labelling processes and updates to packaging material according to Corporate procedure and in compliance with local legislation
- Coordination of timely and relevant communication with regions regarding proposed /planned variations of drug product, support in submission planning and dispatch, monitoring of approvals
- Working with Corporate systems and databases, archiving and reporting( docuBridge(eCTD submission), drugTrack, TrackWise, Loftware Smartflow
Regulatory Affairs Specialist
Alpen Pharma AG
Фармацевтика
1 год 6 месяцев
03.2019 - 09.2020
- Analysis of materials for compliance with regulatory requirements
- Support regulatory submissions for new registrations, renewals, and variations for drug products and dietary supplements (Region of focus?CIS countries (Georgia, Armenia, Azerbaijan,Moldova))
- Communications with manufacturers, MAHs and local partners in the CIS countries
- Support to partners in the region(s) in regards of preparations of responses to DLs and supportingadditional materials
- Maintaining the timelines of submission registration procedures
- Active support to Labelling processes and updates to packaging material according to Corporate procedure and in compliance with local legislation
- Working with Corporate systems and databases, archiving and reporting
Regulatory Affairs Specialist
Фармак, АТ
Фармацевтика
5 лет 9 месяцев
07.2013 - 04.2019
- Analysis of materials for compliance with regulatory requirements
- Support regulatory submissions for new registrations, renewals, and variations for drug products and dietary supplements (Regions of focus:CIS countries (Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan,Kyrgyzstan, Moldova,Tajikistan, Turkmenistan,Uzbekistan))
- Communications with manufacturers, MAHs and local partners in the CIS countries
- Support to partners in the region(s) in regards of preparations of responses to DLs and supporting additional materials
- Maintaining the timelines of submission registration procedures
- Active support to Labelling processes and updates to packaging material according to Corporate procedure and in compliance with local legislation
- Working with Corporate systems and databases, archiving and reporting
Shift master
Фармак, АТ
Фармацевтика
1 год 2 месяца
04.2012 - 06.2013
- Organization and control of performing work in the team in order to ensure the production plan
- Monitoring the progress of the technological process
- The issuance of raw materials, materials
- Ensuring timely maintenance of technological documentation
Ключевая информация
- Computer literacy (MS-office tools), good understanding of RA procedures and databases
- Good analytical, organizational and self-management skills
- Good communication, negotiation and interpersonal capabilities
- Ability to work cross-functionally and in international environment
- Target-oriented personality, able to work on multiple tasks/projects simultaneously
Училась в 1 заведении
Національний технічний університет України «Київський політехнічний інститут імені Ігоря Сікорського»
Факультет біотехнології та інженерії
Киев, 2012
Владеет языками
Английский
выше среднего
Может проходить собеседование на этом языке
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Русский
свободно
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Украинский
родной
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Курсы, тренинги, сертификаты
QA manual, Hillel IT School
Київ, 2023
Olesia
Olesia
Фахівець з реєстрації
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Киев
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полная занятость
Характер работы: удаленная работа, гибридная, в офисе/на месте
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