Senior regulatory affairs specialist

по договоренности
Москва
Опыт работы не важен

Company:

Large international multibusiness company.

Job Responsibilities:

  • Review and assess regulatory documentation prepared by global regulatory department for further submissions to local Regulatory Authorities;
  • Own interactions with Competent Authorities at all steps of product registration process, prepare dossier documents, arrange translation, complete registration dossiers for new products submissions in accordance with yearly registration plan, to ensure in-time receiving of approval documents;
  • Accomplish and ensure in-time submissions and approval of renewals and variations;
  • Arrange payment of local regulatory fees, to ensure import permits obtaining for registrations samples delivery;
  • Identify potential risks and gaps in the assigned projects and propose solutions to mitigate those;
  • Accountable for providing the most accurate and up-dated information about regulatory requirements in geography of responsibility in respond to any intra-company internal request
  • Deliver projects in time, whilst ensuring communication of status and requirements across multiple business functions, organize and hold regular calls and meetings with involved function areas;
  • Ensure regulatory compliance of printed packaging materials
  • Prepare responses to official requests received from the Local Regulatory authorities;
  • To review and ensure compliance of local promotional materials;
  • Understand and act according to regulatory compliance and local policies, track and follow-up on any changes in regulatory requirements of RU
  • Ensure compliance with procedures and systems necessary to maintain proper regulatory records
  • Support other departments with RA information/communication
    • Work Environment:

    • Salary level is discussed on the interview according to candidate's experience.
    • Direct hiring contract.
    • Medical insurance, corporate mobile phone, fitness compensation, annual bonus.
      • Requirements:

      • University degree in pharmaceutical/medical or chemical sciences
      • 2 years + of relevant experience in Regulatory Affairs in local either international company at
      • English language - advanced written, fluent speaker
      • Good knowledge and understanding of local legislation in regulatory field
      • Attentiveness, analytical skills, focus on results, ability to work in multitasking environment
        • Тип занятости:

          Полная занятость, полный рабочий день, у работодателя

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