от компании (организации): ANCOR Consumer Goods в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Лекарственные препараты"
с заработной платой: по договоренности
Вакансия № 12461386 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Среда, 25 сентября 2024 года.
Дата обновления вакансии № 12461386 на сайте Работа в Москве и Московской области (МО, Подмосковье): Четверг, 14 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 12461386 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
не требуется
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: EEU Regulatory Affairs Executive, Moscow (Pharmaceuticals)
GlaxoSmithKline Pharmaceuticals - is one of the world’s leading over-the-counter pharmaceutical companies, including vaccine unit, clinical research and medicines for HIV/infectious diseases treatment (ViiV Healthcare).
Our aim – to help as many people as possible do more, feel better, live longer.
Our company operates in more than 150 countries around the world.
GSK prescription medicines are intended for treatment of a wide range of acute and chronic diseases (COPD, Asthma), including a number of rare diseases (Pulmonary Arterial Hypertension, Systemic lupus erythematosus). Today we are searching for EEU Regulatory Affairs Executive.
- Ensure timely EEU submissions and approvals of applications according to regulatory plan, reviewing it periodically, coordinate approval dates with key stakeholders;
- Identify possible regulatory issues (incl. changes in EEU requirements) and proactively communicate and escalate them, provide feasible solutions;
- Ensure alignment of EEU registered details with original dossiers, corporate databases and across the countries, timely update of the corporate databases;
- Provide support to EEU written standards development and update;
- Identify areas of opportunities and risks related to regulatory activities;
- Communicate with Regulatory Authorities and provide appropriate answers to requests from Regulatory Authorities; 7. Lead timely submissions of post-approval commitments;
- Implement and comply with QMS requirements in the following processes: self inspection (L1 audit), deviation handling, CAPA management;
- Ensure regulatory support to GMP inspections;
- Participate in appropriate trainings for improvement of professional knowledge and skills.
- Knowledge of regulatory policies and climate in one of EEU countries;
- Knowledge of drug development process and laws, regulations and practices affecting the pharmaceutical industry;
- Insightful and forward thinking, ability to recognize, anticipate and discuss potential regulatory challenges;
- Fluent written and speaking English;
- Ability to work within diverse cultures and lead multifunctional matrix teams is beneficial. Leadership skills
- Strong project leadership skills;
- A competent, complete and transparent communicator
- ; Demonstrated ability to make decisions/influence outcomes that include assessment of the potential global impact;
- Analytical in thought process, multi task orientated; demonstrates attention to detail;
- Ability to influence and manage conflicts.
Откликнуться на эту вакансию: EEU Regulatory Affairs Executive, Moscow (Pharmaceuticals)
Предыдущая вакансия:
Вакансия № 12461382 на должность Начальник отдела качества (фарм вет компании) от компании ООО Научно-Технологический Центр БиоИнвест в городе (населенном пункте) Москва