Менеджер по регистрации лекарственных средств

Был больше месяца назад

180 000 ₽

39 лет (родился 11 мая 1986)

Москва

Занятость

полная занятость

Гражданство

Россия

Контакты

Телефон

Почта

Будут доступны после открытия

Профессиональные навыки

Исполнительность
Business Planning
Английский язык
Negotiation skills
Деловая переписка
Работа с большим объемом информации
Грамотность
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Фото, имя и контакты доступны только авторизованным пользователям

Опыт работы 18 лет и 3 месяца

- Февраль 2022 – работает сейчас
- 3 года и 10 месяцев
Regulatory Manager
LLC Italfarmaco
Обязанности и достижения:
• Strategic planning of new product/renewal/variation submissions and approvals within National Russian and EAEU legislation; • Preparation and coordination of all necessary documents for submission (e.g. ND, Leaflet, AW, etc.) • Identify possible critical situations or any other regulatory issues and provide the feasible solution; • Tracking all changes in local legislation and requirements within the scope of area and timely reports. Analyse and provide comments on draft guidance documents for Health authorities; • Proactively communicate issues and potential solutions to HQ; • Communicate with health authorities on standard and non-routine matters. Establish working relations with regulatory authorities; • Regulatory QM system creation and maintaining; • Cross functional interaction with Logistic & Distribution, Marketing, R&Q Compliance group.
- Май 2019 – февраль 2022
- 2 года и 10 месяцев
Language translator / Regulatory adviser
Medconsult / Contract employee
Обязанности и достижения:
• Translation of specific pharmaceutical and technical texts (1-3 Mod, Certificates, etc.); • Preparation ND in accordance with the local Russian requirements and registration dossier; • Preparation of leaflet in accordance with the local Russian requirements and SMPC/Mod 4-5. • Assistance in planning strategy of regulatory submissions.
- Октябрь 2017 – май 2019
- 1 год и 8 месяцев
Regulatory, Quality and PV Manager
Klosterfrau, Russia
Обязанности и достижения:
• Strategic planning of new product/renewal/variation submissions and approvals; • Preparation and coordination of all necessary documents for filing (e.g. ND, Leaflet, AW, etc.) • Identify possible critical situations or any other regulatory issues and provide the feasible solution; • Full support of GMP inspections (8 manufacturing sites; full support of inspectors on site during inspection); • Tracking all changes in local legislation and requirements within the scope of area and timely reports. Analyse and provide comments on draft guidance documents for Health authorities; • Proactively communicate issues and potential solutions to HQ; • Communicate with health authorities on standard and non-routine matters. Establish working relations with regulatory authorities; • PV system creation and maintaining; • SOP system creation; • Budget planning; • Cross functional interaction with Logistic & Distribution, Marketing, Medical departments, R&Q Compliance group; • Interaction with distributors on regulatory questions; • Close cooperation with CRO’s: - Planning and organization of clinical trials; - Interaction on urgent and complex questions.
- Ноябрь 2015 – октябрь 2017
- 2 года
Regulatory Affairs Manager
Santen, Russia
Обязанности и достижения:
• Strategic planning of new product/renewal/variation submissions and approvals; • Preparation and coordination of all necessary documents for filing (e.g. ND, Leaflet, AW, etc.) • Identify possible critical situations or any other regulatory issues and provide the feasible solution; • Full support of GMP inspections (7 manufacturing sites; full support of inspectors on site during inspection); • Participation in the discussion of legislation in AIPM (Russian legislation; EAEU); • Tracking all changes in local legislation and requirements within the scope of area and timely reports. Analyse and provide comments on draft guidance documents for Health authorities; • Proactively communicate issues and potential solutions to HQ; • Communicate with health authorities on standard and non-routine matters. Establish working relations with regulatory authorities; • Budget planning; • Cross functional interaction with Logistic & Distribution, Marketing, Medical departments, R&Q Compliance group; • Interaction with distributors on regulatory questions; • Close cooperation with CRO’s: - Planning and organization of clinical trials; - Interaction on urgent and complex questions.
- Сентябрь 2013 – ноябрь 2015
- 2 года и 3 месяца
Regulatory Affairs Manager
AbbVie LLC, Russia
Обязанности и достижения:
• Ensure timely submissions and approvals of applications according to Regulatory tracking (16 products (Monoclonal antibodies, animal extracts, gel for intestinal administration, etc.)) • Constant review and update regulatory plan • Identify possible critical situations or any other regulatory issues and provide the feasible solution • Full support of GMP inspections within registration process (2 manufacturing sites in Ireland; full support of inspectors on site during inspection) • Participation in the discussion of legislation (Russian legislation; EAEU) • Proactively communicate issues and potential solutions • Prioritize issues within regulatory process to be negotiated with health authorities • Communicate with health authorities on standard and non-routine matters. Establish working relations with regulatory authorities • Coordination of approval dates with Logistic & Distribution, Marketing, Medical departments, R&Q Compliance group • Close cooperation with CRO’s: - Planning and organization of clinical trials (registration clinical trials – 1 clinical trial); - Interaction on urgent and complex questions. • Tracking all changes in local legislation and requirements within the scope of area and timely reports. Analyse and provide comments on draft guidance documents for Health authorities • Assess the regulatory history of products or projects and use information to elaborate strategies of standard submissions. Monitor progress against targets • Managing the Regulatory Affairs Officer • Preparation timely answers to requests from Regulatory Authorities and authorise answers according to the Chart of Authority for Documents / Correspondence Approval.
- Май 2012 – сентябрь 2013
- 1 год и 5 месяцев
Regulatory Affairs Manager
ZAO «GlaxoSmithKline Trading»
Обязанности и достижения:
• Ensure timely submissions and approvals of applications according to Regulatory tracking (personal responsibility for 12 products (heparins, CNS, etc.)) • Review and update regulatory plan periodically • Identify possible critical situations or any other regulatory issues and provide the feasible solution • Proactively communicate issues and potential solutions • Prioritize issues within regulatory process to be negotiated with health authorities • Communicate with health authorities on standard and non-routine matters. Establish working relations with regulatory authorities • Coordination of approval dates with Logistic & Distribution, Marketing, Medical departments, R&Q Compliance group • Close cooperation with CRO’s: - Planning and organization of clinical trials (registration clinical trials – 3 clinical trials); - Interaction on urgent and complex questions. • Tracking all changes in local legislation and requirements within the scope of area and timely reports. Analyse and provide comments on draft guidance documents for Health authorities • Manage the group of regulatory affairs executives (3 people; 45 products) • Prepare timely answers to requests from Regulatory Authorities and authorise answers according to the Chart of Authority for Documents / Correspondence Approval.
- Июль 2009 – май 2012
- 2 года и 11 месяцев
Regulatory Affairs Executive
ZAO «GlaxoSmithKline Trading»
Обязанности и достижения:
• Preparation full package of documents for RA procedures (new registration, renewal, variations, prices, EAN-codes registration and safety updates), including local documentation (ND, leaflet text, packaging materials), contact with Authorities. • Preparation different letters to Roszdravnadzor and the rest Authorities for certification aims (drug products, medical device, FMCG). • Accounts. • Interaction with the departments of the company. • Business correspondence. • Different support RA managers.
- Сентябрь 2007 – июль 2009
- 1 год и 11 месяцев
RA assistant
“Polpharma” (Poland)
Обязанности и достижения:
• Preparation full package of documents for RA procedures (new registration, renewal, variations, prices and EAN-codes registration), including local documentation (ND, leaflet text, packaging materials), contact with Authorities. • Preparation different letters to Roszdravnadzor and the rest Authorities for certification aims (drug products, medical device, FMCG). • Accounts. • Business correspondence. • Different support RA managers.

Образование

- Высшее образование
- 2009
Moscow State Medical Academy named after I. M. Sechenov
Факультет: Pharmaceutical
Специальность: Pharmacist

Обо мне

Дополнительные сведения:

Excellent communication and negotiating skills, team player, ready for business trips, driving license. Computer Skills – experienced user (MsWord, Excel, Powerpoint, Photoshop, CorelDraw) Hobbies: Traveling, Music, Sport, Cars, Ecological Agriculture. Исполнительность, Business Planning, Английский язык, Negotiation skills, Деловая переписка, Работа с большим объемом информации, Грамотность