от компании (организации): GSK в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Фармацевт"
с заработной платой: по договоренности
Вакансия № 18605645 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Среда, 18 сентября 2024 года.
Дата обновления вакансии № 18605645 на сайте Работа в Москве и Московской области (МО, Подмосковье): Воскресенье, 22 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 18605645 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
более 6 лет
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Regulatory Affairs Manager
We are looking for Regulatory Affairs Manager who will add value to business by ensuring timely submissions and approvals for new products managed by GSK as well as maintenance of registered licenses in alignment with national Russian regulations, EEU regulations and corporate policies and procedures. RAM will support ONCO and pharma.
Key Responsibilities
- Ensure timely submissions and approvals of applications for registration, confirmation of registration, and variations to registration dossier according to regulatory plan, reviewing it periodically, coordinate approval dates with key stakeholders;
- Identify possible regulatory issues (incl. changes in local requirements) and proactively communicate and escalate them, provide feasible solutions;
- Ensure alignment of registered details with original dossiers and corporate databases, timely update of the corporate databases;
- Lead written standards development and update;
- Identify areas of opportunities and risks related to regulatory activities;
- Lead timely submissions of post-approval commitments;
- Foster monitoring and shaping of regulatory environment, communicate with Area Regulatory Hub and Global Regulatory Intelligence teams, analyze and provide comments on draft guidance documents for Regulatory Authorities;
- Support maintenance of the Regulatory Intelligence database;
- Participate in appropriate trainings for improvement of professional knowledge and skills;
- Ensure back-up for Artwork and Pack Executive and Quality and Risk Management Manager (artwork proofreading process).
Requirements:
- Postgraduate or graduate in pharmacy/biology/chemistry with considerable experience in Regulatory Affairs with managerial responsibilities;
- Knowledge of regulatory policies in Russia; 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 read, analyze and interpret complex regulatory documents and to respond effectively to sensitive inquires or complaints;
- Ability to work within diverse cultures and lead multifunctional matrix teams is beneficial;
- Strong management and project leadership skills;
- 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;
- Discipline; ability to organize the activities within the granted autonomy and to make rational use of working time.
What we can offer:
- Competitive salary
- Medical insurance, life insurance
- Meal allowance
- Mobile compensation
- Internal and external educational courses and trainings
- Professional and career development opportunities
- Corporate car/ car allowance
Откликнуться на эту вакансию: Regulatory Affairs Manager
Предыдущая вакансия:
Вакансия № 18605643 на должность Охранник от компании ООО Ангел в городе (населенном пункте) Солнечногорск