Regulatory Affairs Manager

Была больше месяца назад

По договорённости

37 лет (родилась 03 апреля 1988)

Москва

Занятость

не указано

Гражданство

Россия

Контакты

Телефон

Почта

Будут доступны после открытия

Фото, имя и контакты доступны только авторизованным пользователям

Опыт работы 11 лет и 7 месяцев

- Апрель 2020 – март 2022
- 2 года
Sr. Manager Regulatory Affairs
FarmaMondo, Москва
Pharmaceutical distributor
Обязанности и достижения:
• Registration of new products/re-registration/ variation submissions of medicinal products for Russian, EAEU and CIS market (Belarus, Kazakhstan, Ukraine, Armenia, Georgia, Azerbaijan and Uzbekistan) • Participation in localization project in Russia • Project management of medical device projects (Russia, Belarus, Kazakhstan, Armenia, Georgia, Uzbekistan), preparation of submission packages, monitoring and follow up of the registration process • Development of regulatory strategies for Russia, EAEU and CIS (Belarus, Kazakhstan, Ukraine, Armenia, Georgia, Azerbaijan and Uzbekistan) and consulting of partners • Preparation and compilation of regulatory submission dossiers for Russia and CIS (Belarus, Kazakhstan, Ukraine, Armenia, Georgia, Azerbaijan and Uzbekistan) according to the local requirements and submission to the relevant Authority • Monitoring and follow up of the registration process • Order and import of registration samples and required documentation for samples submission • Local GMP compliance submission (documentary) in Ukraine and supporting of Quality team with GMP submissions in Russia/ EAEU • Project lead function including coordination of submissions in several markets, project management activities, working with vendors and different partners • Working, collaboration and mentoring with CIS partners (Belarus, Kazakhstan, Ukraine, Armenia, Georgia, Azerbaijan and Uzbekistan) • Accurate reporting and archiving in relevant systems according to the local requirements and companies’ requirements • Working in cross-cultural environment with different companies and teams: EU, USA, India, as well as different product profiles • Direct collaboration and communication with companies’ partners and partners teams • Working in multitasking environment • Budgeting for Russia, EAEU and CIS projects • Prepare presentations and presenting for different partners: regulatory environment in Russia, EAEU and CIS countries, projects follow up, legislation updates, development strategies etc • Presenting Russia and EAEU at Eucope Regulatory Affairs event (the European Confederation of Pharmaceutical Entrepreneurs)
- Май 2019 – апрель 2020
- 1 год
Manager Regulatory Affairs
Amgen, Москва
Pharmaceutical company
Обязанности и достижения:
• Registration of new products/re-registration/ variation submissions of medicinal products for Russian and CIS market (Belarus, Kazakhstan, Ukraine, Armenia, Georgia) • Development of regulatory strategies for Russia and CIS (Belarus, Kazakhstan, Ukraine, Armenia, Georgia) • Preparation and compilation of regulatory submission dossiers for Russia and CIS (Belarus, Kazakhstan, Ukraine, Armenia, Georgia) according to the local requirements and submission to the relevant Authority • Monitoring and follow up of the registration process • Order and import of registration samples and required documentation for samples submission • Local GMP compliance submission (documentary) in Ukraine and Belarus • Project lead function including coordination of submissions in several markets, project management activities • Working, collaboration and mentoring with CIS partners (Belarus, Kazakhstan, Ukraine, Armenia, Georgia) • Accurate reporting and archiving in relevant systems according to the local requirements and Amgen requirements • Direct collaboration and communication with headquarter • Working in cross-cultural and multitasking environment • One junior person subordinate • Budgeting for Russia and CIS projects • Prepare presentations and presenting on monthly, quarter and year basis for different HQ team activities: projects follow up, legislation updates, development strategies etc • Participation in medical device projects (software)
- Июнь 2016 – май 2019
- 3 года
Sr. Regulatory Affairs Associate
Amgen, Москва
Pharmaceutical company
Обязанности и достижения:
• Registration of new products/re-registration/ variation submissions of medicinal products for Russian and CIS market (Belarus, Kazakhstan, Ukraine, Armenia, Georgia) • Development of regulatory strategies for Russia and CIS (Belarus, Kazakhstan, Ukraine, Armenia, Georgia) • Preparation and compilation of regulatory submission dossiers for Russia and CIS (Belarus, Kazakhstan, Ukraine, Armenia, Georgia) according to the local requirements and submission to the relevant Authority • Monitoring and follow up of the registration process • Order and import of registration samples and required documentation for samples submission • Local GMP compliance submission (documentary) in Ukraine and Belarus • Project lead function including coordination of submissions in several markets, project management activities • Working, collaboration and mentoring with CIS partners (Belarus, Kazakhstan, Ukraine, Armenia, Georgia) • Budgeting for Russia and CIS projects • Accurate reporting and archiving in relevant systems according to the local requirements and Amgen requirements • Direct collaboration and communication with headquarter • Working in cross-cultural and multitasking environment
- Ноябрь 2015 – май 2016
- 7 месяцев
Sr. Regulatory Affairs Associate
Parexel International RUS, Москва
Clinical Research Organization
Обязанности и достижения:
• Registration/re-registration of medicinal products for Russian market • Preparation and compilation of regulatory submission dossiers • Monitoring of registration process • Supporting with strategy recommendations for regulatory procedures in Russia and CIS countries (Belarus, Kazakhstan, Ukraine) • Project lead function including coordination of submissions in several markets, project management activities such as proposals, revenue recognition • Supporting regulatory submissions for CIS countries (Belarus, Kazakhstan, Ukraine) • Global Coordinator of Artwork Development for submissions worldwide • Providing trainings on packaging and packaging systems • Supporting of Regulatory team with tasks related to submissions to Regulatory authorities worldwide • Working with several reporting and archiving systems for different partners • Working in cross-cultural and multitasking environment
- Май 2012 – ноябрь 2015
- 3 года и 7 месяцев
Regulatory Affairs Associate
Parexel International RUS, Москва
Clinical Research Organization
Обязанности и достижения:
• Registration/re-registration of medicinal products for Russian market • Preparation and compilation of regulatory submission dossiers • Monitoring of registration process • Supporting with strategy recommendations for regulatory procedures in Russia and CIS countries • Global Coordinator of Artwork Development: Preparation and coordination the artwork development, approval process; working with various Regulatory Affairs and Supply Chain departments, Graphic Design Companies, Quality Assurance and Quality Control departments • Providing trainings on packaging and packaging systems • Supporting regulatory submissions for CIS countries • Supporting of Regulatory team with tasks related to submissions to Regulatory authorities worldwide • Supporting CTD formatting and document quality reviews • Working in cross-cultural and cross-functional environment
- Октябрь 2011 – май 2012
- 8 месяцев
Regulatory Affairs Associate
Dokumeds, Москва
Clinical Research Organization
Обязанности и достижения:
• Preparation, maintenance of regulatory submissions/ notifications to Regulatory Authorities, Local Ethics Committees • Adverse event reporting • Preparation of export/ import licenses • Collect regulatory documentation • Work with MoH/ internal database, maintenance of documentation the clinical trials, keeping contact with Regulatory Authorities, Local Ethics Committee members • Adaptation/ translation of Patient Information Sheets
- Сентябрь 2010 – октябрь 2011
- 1 год и 2 месяца
Clinical Trial Assistant
Dokumeds, Москва
Clinical Research Organization
Обязанности и достижения:
• Preparation, maintenance of regulatory submissions to Regulatory Authorities, Local Ethics Committees • Preparation of ISFs, Patient Files, TMFs’ maintenance, documents compilation • Translation of study related/ regulatory documents • Collect regulatory documentation • Organization of shipments