Вакансія Senior Regulatory Specialist

Компанія: Reckitt Benсkiser / Реккітт Бенкізер Україна
Місто: Украина, Киев, проспект Степана Бандеры, 28А
Вулиця місця роботи: Украина, Киевская область, Киев, проспект Степана Бандеры
Розміщена: 8 лип. 2018
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Опис вакансії

RB is the world's leading consumer health and hygiene company.

Every day, across 60 countries, we work with the best people to challenge conventional thinking and strive to find even better ways to give people innovative solutions for healthier lives and happier homes.

High impact, consumer-led research is the heart of the company's success. Ranked in the TOP 20 on the London Stock Exchange, our relentless drive to outperform has trebled our revenue since 2000 and quadrupled our market cap.

We announce vacant position Senior Regulatory Specialist

Key responsibilities:

  • Review, evaluation, compilation, submission and tracking of Marketing Authorisations, applications and reports for submissions of Healthcare products
  • Review, evaluation, compilation, submission and tracking of Marketing Authorizations renewal and variations applications and reports for submissions of Healthcare products
  • Responsible for the timely response to Health Authorities requests related to regulatory submissions
  • Ensure product labelling for all products comply with product dossiers and relevant regulations
  • Perform activities to ensure that regulatory timelines are properly established, maintained and on-target
  • Interact with upper level Regulatory Affairs Departments to assure timely provision of regulatory documentation and related elements necessary to support registration, renewals and variation submission of company's products
  • Assist Local and Regional Regulatory Teams in analysing country product data, Regulatory legislation and providing country specific information
  • Provides project team representation and direction in managing information from/to other departments regarding Regulatory submissions

We expect:

  • University degree
  • Experience in regulatory ~ 3 years is acceptable
  • Good knowledge of Word, Excel, Outlook, Powerpoint, SAP
  • English - upper-intermediate level
  • Effective communication, interpersonal team involvement and organizational skills with effective ability to adjust to change
  • Ability to handle multiple tasks and priorities
  • Result oriented, fast learner, flexible to changes, team player

We propose:

  • Official hiring + social package
  • Getting X-functional and international experience
  • Getting quick various experience related to real business environment
  • Implementation of the initiatives
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GlaxoSmithKline Ltd Украина, Киев