EastHORN Clinical Services is a clinical research organisations (CRO) in Europe. We operate in over 20 countries in the region with an experienced staff comprised largely of physicians and PhDs. We serve global pharmaceutical and biotechnology companies in the development of new medicines and modern medical technologies. The company has operations throughout Europe and since starting 18 years ago, we have expanded significantly.

Our international clients value our enthusiastic, flexible and quality-focused professional approach to meeting their needs, and we are continuing to grow further. To support our future development, we are currently looking for a

Regulatory Specialist

Job summary

As a Regulatory Specialist you will be expected to provide clerical support to project team during the study conduct, assist in regulatory submission and Clinical Research Associate activities at the study start and perform other administrative duties as assigned by management.

We are searching for a positive and energetic person, eager to learn, push forward administrative processing of the documents and function well in the project team. The suitable candidate shall have desire to develop in Regulatory activities and specialise with the time in Regulatory submissions and requirements for Poland.

Main Tasks of the Position

  • Participates in all activities that lead to start up of investigational sites
  • Takes part in the communication with Regulatory Authorities and Ethics Committees
  • Interacts with Customers when receiving requirements from Regulatory Authorities
  • Provides interpretative assistance of guidance documents and regulatory rules and ensures their communication through company policies and procedures
  • Provides training and support to CRAs in order to collect all necessary documents for start up package and IP release
  • Close collaboration with Regulatory Lead and Project Team during entire project
  • Performs tasks according to relevant SOPs and completes the SOPs training in given timelines

Required Qualifications, Experience, Competencies

  • Excellent written and oral communication skills in English and Georgian
  • Excellent organizational and time management skills
  • Attention to detail
  • Ability to work well within a team
  • Flexibility, adjustability, initiative taking
  • Open to learn new things and communicate across countries and cultures
  • Independence in work
  • Computer competency
  • Previous experience in clinical research field is an advantage
  • Background of natural science is an advantage
  • Position is highly suitable for Study Coordinators

Benefits

  • Working with experienced and very professional and supportive team
  • Possibility to grow within the Company
  • Competitive remuneration
  • Medical insurance paid by the company
  • Eligibility to the Company Bonus scheme
  • Flexible working time

If you are a reliable and positive personality and would like to contribute to the further success of a dynamic young company in a growing market, please send your CV and motivation letter in English to: careers@easthorn.eu or complete the form below:

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