- Полный рабочий день
Regulatory Affairs Specialist
31 октября 2017, 11:31
Preparation of dossier for various regulatory submissions (NDA, Renewal, Variations, EAEU compliance), including:
- documents translation,
- local Normative document preparation,
- PIL writing,
- packaging materials artworks coordination
- completion of the dossier.
- Assurance of documents compliance with the regulations of the Russian Federation.
- Assurance of timely submission and documentation flow for timely approval.
- Monitoring of Russian regulatory environment.
- University degree in Pharmacy or Natural Sciences (Pharmaceutical, Medical or Chemical)
- Experience in regulatory area in a Pharmaceutical Company (could be minimal experience)
- Familiar with local and EMA (desirable) regulations
- English – upper-intermediate level
- Advanced computer skills (Microsoft Word, PowerPoint, Excel)
Skills and attitude required
- To be self-disciplined and well organised. Possess a strong sense of responsibility. Have a good track record of working organised and independently while meeting strict deadlines
- Fast learner
- Quality Orientation
- Eye for detail. Able to do the “head’s down” work in addition to the other requirements.
- Team working / Collaboration with others. Good communication skills
- High level of self-motivation.
- Flexibility, adaptability and proactive nature in order to meet the various demands and priorities
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