Резюме № 9563812
Обновлено 24 ноября 2015
Обновлено 24 ноября 2015
Head of Regulatory Affairs
Была больше месяца назад58 лет (родилась 08 марта 1967), cостоит в браке, детей нет
Москва
Сходненская
Занятость
полная занятость
Гражданство
Россия
Контакты
Телефон
Почта
Фото, имя и контакты доступны только авторизованным пользователям
Опыт работы 19 лет и 5 месяцев
- Август 2012 – сентябрь 2015
- 3 года и 2 месяца
Head of Regulatory Affairs
Representative Office Sun Pharmaceutical Industries Ltd, Russia (following merge with Ranbaxy), МоскваОбязанности и достижения:
Leading the Regulatory Department (till mid 2013 it was Regulatory and Quality Assurance Department) in close collaboration with company International Regulatory Affairs, budgeting and managing all regulatory activities with company products Rx, OTC and in-licenced products, synchronizing work with regulatory colleagues in CIS countries, supporting regulatory policy and cross-business regulatory initiatives within the company, insuring quality of Regulatory dossiers and compliance of products Regulatory status, managing quality matters with Quality Certification Laboratories and Distributors; collaborating with Medical department on PV matters, preparation Pre-Clinical and Clinical part of Regulatory dossier including Clinical Trials Applications, working with Demand Planning, Marketing and Business Development departments to minimize regulatory risks for investigational and marketed products, managing packaging artworks development including for local packaging with third party, writing and implementing Regulatory SOPs, revising promotional materials, maintaining strategic communication with country Regulatory Authorities, participating in work of AIPM influencing changing regulation affecting company, communicating with IMEDA when necessary, participating in industry conferences.- Март 2009 – февраль 2012
- 3 года
Head of Medical and Regulatory Affairs
OOO Grunenthal, МоскваОбязанности и достижения:
• Building the RA&Medical Department from its start-up, including establishing contractual relationship with HQ (Grunenthal GmbH, Germany) in all main aspects of Department’s functions (Regulatory, Drug Safety, Medical Affairs) for Rx products, OTC, Medical Devices and Food Supplements, building well motivated team, • Running the Department in accordance with Russian Regulation and company strategy, • Reporting to HQ (R&D) as solid line and to local General Manager as dotted line, • Planning/managing regulatory activities, • Establishing local Pharmacovigilance system, arranging reporting, • Delivering trainings to colleagues, • Planning/controlling budget (in the frames of divisional structure of company), • Collaboration with CRO, in Clinical Trials, • Developing relevant local SOPs and control of adherence of local and corporate ones. • Work with Russian Health Regulatory Authorities maintaining ethical relationship, • Collaboration with Marketing, KOLs, revising/approval promotional materials, providing medical information. • Collaboration with Legal consulting and Recruiting companies, • Hiring and managing of service providers, • Work with Certification centers, • Managing Regulatory process in Belarus, • Close collaboration with Ukraine Rep. office on Regulatory and Drug Safety matters, • Together with HQ and Legal consulting company developing a legal strategy for registration of products in other CIS countries, • Participation in international Grunenthal meetings, delivering presentations, • Attending conferences of Russian Health Regulatory Authority and meetings of AIPM- Февраль 2008 – март 2009
- 1 год и 2 месяца
Acting Local Pharmacovigilance Manager/Senior Associate Global Safety
OOO Amgen, МоскваОбязанности и достижения:
In close collaboration with Drug Safety Management (UK) building from start-up a Drug Safety Unit in Amgen Russian Office. Managing Regulatory activities for Clinical Trials. Collaboration with Russian Health Authority in developing the new Regulation in Pharmacovigilance. Managing Pharmacovigilance work for Marketed products and Clinical trials. Training of investigators and local Amgen staff. Creating local operating procedures and control of adherence. Tutoring Safety Junior colleague. Collaboration with CROs. Maintaining good working relationship with Russian Regulatory Officials. Passed training/Certification in the EU Pharmacovigilance system. Training course hosted by Management Forum Ltd. (with MHRA participation), London, the UK completed in December 2008.- Август 2006 – январь 2008
- 1 год и 6 месяцев
Acting Regulatory Affairs Manager
OOO Wyeth, МоскваОбязанности и достижения:
Joined company at start-up of Russian legal entity as a Regulatory Affairs Specialist. In 2007 started acting as Regulatory Affairs Manager Pharma reporting to Country Manager, Russia and CEE Regulatory Affairs Director (located in Austria): In close collaboration with R&D (located in the UK) preparation and submission of documents for registration of new products. Managing Regulatory, Pharmacovigilance and support of Quality Compliance work. Together with Regulatory and Commercial (Austria) planning Regulatory activities in the RF and Regulatory budget. Providing support to distributors. Managing of Regulatory Outsourcing Company activities. Participation in AIPM and the MoH meetings. Hiring and tutoring Regulatory staff. Maintaining good working relationship with Russian Regulatory Officials.- Декабрь 2000 – август 2006
- 5 лет и 9 месяцев
Regulatory Affairs Specialist
Pfizer International LLC Moscow Representative OfficeОбязанности и достижения:
(2000-2003 – Pharmacia N.V./S.A. Moscow Representative Office. Joined Pfizer in 2003 following acquisition of Pharmacia Inc.) Managing and co-ordinating activities related to Regulatory support of pharmaceutical products (Rx including biotechnological ones and OTC (also as Food Supplements and Healthcare products)) and Medical Devices. Registration of new products. Providing support to ClinOps, BD, QA and DS Departments. Maintaining good working relationship with Russian Regulatory Officials.- Ноябрь 1999 – ноябрь 2000
- 1 год и 1 месяц
Regulatory Affairs Officer
Nycomed Distribution Center, CIS (Nycomed Amersham Representative Office), МоскваОбязанности и достижения:
Regulatory support for all company’s products in Russia. Regulatory support and co-ordination of regulatory activities in the CIS countries.- Декабрь 1995 – ноябрь 1999
- 4 года
Pharmaceutical Adviser
Organon Agencies B.V. Moscow Representative Office, МоскваОбязанности и достижения:
Building and managing the Regulatory Department in Moscow. Executing Regulatory and Pharmacovigilance work with all company products. Providing trainings in Drug Safety/Quality Complaints reporting to local staff. Participation in developing Recall procedure. Designing and Licensing of Pharmaceutical Warehouse. Obtaining Pharmaceutical Licence quickly within scheduled time, building and managing Warehouse team. Supporting inspections by Authorities. Supporting business clients in obtaining Import Licences. Maintaining good working relationship with Russian Regulatory Officials.
Образование
- Высшее образование
- Дневная/Очная
- 1989
Обо мне
Дополнительные сведения:
Idea of a new job is caused by acquisition and restructuration of company
Reading, sport, photo
PROFESSIONAL SKILLS:
Strong Managerial and Administrative skills
Knowledge of Russian Pharmaceutical and Medical Regulation, basic knowledge of Tax and Labour Regulation, basic knowledge of European Pharmacovigilance Regulation
Fluent English
Presentation skills (in Russian and in English)
Business Communication and IT skills
Иностранные языки
- Английский язык — cвободное владение
Водительские права
- B — легковые авто
Фото, имя и контакты доступны только авторизованным пользователям
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