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EEU Regulatory Affairs Executive/Специалист по регистрации в ЕврАзЭс

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Заработная плата:

по договоренности

Дата публикации:

18.04.2017

Тип занятости:

Город:

Москва

Требуемый опыт работы:

Описание:

Our client - a big international pharmaceutical company is looking for EEU Regulatory Affairs Executive

To add value to business by ensuring timely submissions and approvals for new products within EEU managed as well as maintenance of registered licences in alignment with EEU regulations and corporate policies and procedures.

Supports 5 EEU countries – Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan.

Key Responsibilities

  • Ensure timely EEU submissions and approvals of applications via MRP or DCP 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 procedures 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.
  • Lead timely submissions of post-approval commitments.
  • Implement and comply with QMS requirements in the following processes: management monitoring (L1 Audit), deviation handling, CAPA management.
  • Ensure regulatory support to GMP inspections.

Knowledge / Education / Previous Experience required to perform this job

Education

  • Postgraduate or graduate in pharmacy/biology/chemistry with experience in Regulatory Affairs in one of EEU countries.

Experience

  • 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.
  • Advanced level of 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.

Compensation:
• Competitive compensation package
• World-renown brand name
• You'll get a challenging job as well as excellent opportunity for further professional growth with a dynamic international business