EastHORN Clinical Services is a clinical research organisations (CRO) in Europe. We operate in over 15 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 16 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 Assistant Bulgaria, Czech Republic, Spain

Job summary

As a Regulatory Assistant you will be expected to provide clerical support to Regulatory Affairs department, maintain and organize the department trackers and databases, perform data entry and maintain regulatory documents files etc. Reporting to Regulatory Manager, you will be a key member of the Regulatory Affairs team companywide.
We are searching for an ambitious and energetic person, with certain knowledge in clinical research who will be able to function well in the Regulatory and study teams and is willing to develop further in Regulatory field. 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

  • Provides clerical support to Regulatory team (e.g., word processing, proofreading and editing correspondence, large and small documents, mailings, shipment of study files, fax and photocopy documents, assemble study documents, and arrange meetings, supports Regulatory Leads/ Regulatory Manager, etc.)
  • Collects and maintains required regulatory documents
  • Assists in collecting information from various departments (e.g., Project Management, Clinical, QA, etc.) to support regulatory projects, as needed
  • Assists in development and implementation of key regulatory documents, templates etc. as required for the regulatory submissions
  • Maintains and organizes department trackers and databases, as required
  • Performs data entry and maintenance of selected study tracking databases
  • Maintains regulatory document files for assigned projects
  • Supports the preparation and organisation of Regulatory trainings within the company
  • Timeous processing of Travel arrangements, conferences, workshops and training activities for the Regulatory Affairs department
  • Participates at projects conferences and takes meeting minutes
  • Uploads and performs quality checks of documents for eTMF
  • Performs other administrative duties as assigned by management
  • Continuously improves knowledge regarding regulatory submissions and requirements
  • Performs tasks according to relevant SOPs and completes the SOPs training in given timelines

Required Qualifications, Experience, Competencies

  • University degree, preferably in medicine, pharmacy, or related paramedical fields
  • At least 1 year experience in clinical research at pharma or CRO
  • Understanding of ICH and GCP guidelines, working knowledge of document review
  • Strong organizational and interpersonal skills
  • Hands-on, action-oriented, continuous improvement minded
  • Proven ability to handle multiple projects and meet deadlines
  • Willingness to work with changing priorities with enthusiasm
  • Self-starter, with the ability to work and learn independently
  • Ability to work under pressure, communicate and present information
  • Excellent analytical skills and superb attention to detail
  • Excellent written and oral communication skills in English and local language
  • Very good computer literacy

Benefits

  • Working with experienced and very professional and supportive team
  • Possibility to gain experience in RA and EC submissions internationally
  • Possibility to grow within the Company
  • Competitive remuneration
  • Flexible working time
  • Eligibility to the Company Bonus scheme
  • Country Specific benefit package

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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