от компании (организации): ANCOR в городе (населённом пункте): Москва, Россия
в отрасли экономики "Производство, сельское хозяйство" → "Инженер"
с заработной платой: по договоренности
Вакансия № 27336866 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Суббота, 31 августа 2024 года.
Дата обновления вакансии № 27336866 на сайте Работа в Москве и Московской области (МО, Подмосковье): Понедельник, 23 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 27336866 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
3–6 лет
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Senior Regulatory Affairs Specialist / Старший специалист по регуляторным вопросам
International pharmaceutical company is looking for Senior Regulatory Affairs Specialist (maternity leave position)
Main purpose:
- Develop country specific Labels (package inserts) for company's products;
- Filling and getting approval of regulatory labeling variations for drug products and for medical devices in Russia;
- Support of new registration in Russia (with focus on labeling and clinical/non-clinical parts of dossier);
- Effectively interact with the RA personnel at local/area and global levels as well as cross-functionally in the affiliate.
Key responsibilities:
- Coordinate handling of company core date sheet (CCDS) updates;
- Review promotional, non-promotional materials per agreed guidelines & within required time-frame;
- Keep abreast of emerging legislation, local related to registration and highlight the potential impact on the business;
- Gather a thorough knowledge of the registration files and all related company product documentation. Keep up-to-date on Company products;
- Provide Regulatory support in implementing affiliate strategy;
- Work with area and global regulatory teams with respect filing of label updates (new indications, safety updates, etc.) to gain respective approvals in case of deviation from CCDS, as well as in terms of optimal regulatory strategy for label updates filings;
- Work with commercial organization: present RA function in brand teams’ meetings related to assigned products. Align label strategies as well as timing for filings and approvals for assigned brands;
- Review and sign-off registration packages prior to submission. This includes label changes and to ensure compliance with local and corporate requirements;
- Ensure that all Regulatory submissions (new registrations, renewals, variations, notifications) are prepared and filed in a timely manner for all Company products marketed and/or registered in Russia or new products intended to be marketed in Russia. Follow up with Labeling support of these submissions;
- Gain Regulatory Authority approval for marketing authorisations for new products;
- Maintain all existing product marketing authorisations and gain Regulatory Authority approval of variations (amendments) to these authorisations as required;
- Manage any further information requests from local Regulatory Authority in a timely manner, ensuring local authority’s expectations are accurately translated for Company Area Regulatory. Submission of any subsequent responses/product documentation updates to local Regulatory Authority;
- Review Product Information in accordance with legal and regulatory requirements; ensure that all prescribing information is accurate, updated and approved by both Company and relevant Regulatory Authority in accordance with Company policies and local regulations;
- Participate in packaging projects implementation within agreed timeframe, including development with third parties of updated artwork for cartons, labels and leaflets in accordance with Company requirements and local regulations;
- Provide and/ or manage language translations, as required;
- Provide support and, if required, back-up to other employees of Regulatory Affairs Department;
- Improve professional skills and knowledge; attends Company’s seminars for employees to increase their qualification.
Skills& knowledge:
- At least 3 years experience in Regulatory Affairs;
- Experience in developing country-specific labels;
- Experience working effectively in complex matrixed environment;
- Proactive verbal and written communication style at all levels;
- Solution driven style;
- Ability to work independently with minimal supervision;
- Demonstrated success in negotiating skills;
- Strong proven personal development, motivational skills and high level of initiative;
- Strong interpersonal and organizational skills;
- Understands business needs and impact of regulatory issues on these;
- Comprehensive knowledge of LOCAL Regulatory Affairs requirements;
- At least Upper-Intermediate in English both verbal and written;
- Efficient Computer Skills;
- Good presentation skills.
Откликнуться на эту вакансию: Senior Regulatory Affairs Specialist / Старший специалист по регуляторным вопросам
Предыдущая вакансия:
Вакансия № 27336835 на должность Преподаватель онлайн и офлайн курсов по "Охране труда" от компании Onstudy в городе (населенном пункте) Москва