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 Associate in Bulgaria, Czech Republic, Spain

Job summary
As a Regulatory Associate you will be expected to assist Regulatory Leads/ Regulatory Manager in development and implementation of strategies for the earliest possible approval of regulatory submission, provide Administrative and Secretarial support to Regulatory Affairs department, assist in development and implementation of key regulatory documents, templates etc. Reporting to Regulatory Manager, you will be a key member of the Regulatory Affairs department companywide.
We are searching for an ambitious and energetic person, with strong desire to develop in Regulatory field who will be able to function well in the Regulatory and project teams. 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

  • Works cross-functionally with Regulatory Leads, key internal departments, and external regulatory bodies to support the earliest possible approval of regulatory submission
  • Coordinates and collects 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
  • Assists in the coordination, preparation and reviews of document packages for regulatory submissions ensuring compliance
  • Contacts Regulatory Authorities / Ethics Committees per project needs
  • Assists in compilation and/or review of IP release packages in a timely manner
  • Maintains regulatory document files for assigned projects
  • Assists Study Team, as needed in communication of study requirements to all individuals involved in the study
  • 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
  • Establishes and maintains effective relationships with colleagues, third party service providers and regulatory authorities
  • Continuously improves knowledge regarding regulatory submissions and requirements

Required Qualifications, Experience, Competencies

  • University degree, preferably in medicine, pharmacy, or related paramedical fields. Alternatively, certified training courses in Regulatory Affairs
  • At least 2 years’ experience in clinical research at pharma or CRO
  • Regulatory submission knowledge and 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
  • Ability to read, interpret, and apply policies and procedures
  •  Ability to identify problems, recommend solutions, organize and analyze 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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