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, the Netherlands

Job summary

As a Regulatory Specialist you will be expected to actively participate in all start up activities and perform CA and EC submissions. You will be responsible for communication with Regulatory Authorities and Ethics Committees and function as an expert for Regulatory issues in the NL. Reporting to Clinical Operations Manager, you will be a key member of the Clinical Operations
team in the country.

We are searching for ambitious and energetic person, able to undertake challenges in the project, push forward submissions and function well in the project team. The desired person shall be open to cross cultures communication and cooperation and shall be significantly independent in their performance.

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

Required Qualifications, Experience, Competencies

  • Excellent knowledge of the clinical trial process and ICH/GCP and local requirements/guidelines
  • The position is suitable for candidates with some clinical research and RA and EC submissions knowledge and background such as Project/ Trial Assistants and CRAs
  • Open to learn and develop
  • Excellent organizational and time management skills
  • Skills to handle multiple priorities and to work with deadlines and under pressure
  • Excellent written and oral communication skills
  • Fluent in written and verbal English and Dutch
  • Computer skill

Benefits

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

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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