Drug Regulatory Affairs Group Head

Уровень зарплаты
Город
Требуемый опыт работы
з/п не указана
Москва
3–6 лет

Our Client – a leading international pharmaceutical company

Reporting to: Drug Regulatory Affairs Head

Main Duties and Responsibilities:

  • Managing effective work of Regulatory Affairs function in Russia
  • Ensure all regulatory submissions in Russia are executed in a timely manner in compliance with corporate standards and local regulatory requirements
  • Management and development of RA team
  • Ensure regional input to & execute regulatory strategies
  • Monitor changes in local trade Association, Code and National legislation and forward information to local /regional/regional groups and feedback into strategy in a timely manner
  • Exchange regulatory information & intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner
  • Planning, managing department budget

Qualifications, education and experience required

  • University degree (medical, pharmaceutical, life-science)
  • From 5 years of years of directly related experience with regulatory affairs
  • Understanding of local regulatory activities and how they affect projects and processes
  • Ability to understand and communicate scientific/clinical information
  • People management and development experience
  • Excellent project management skills, communication and presentation skills, analytical skills, quick-learner within changing environment
  • Team player, driven for results
  • Fluent English required
  • Advanced computer skills (Microsoft Word, PowerPoint, Excel, Project)

Тип занятости

Полная занятость, полный день
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