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

Head, Regulatory Affairs, Europe

Job summary

As an experienced Head of Regulatory Affairs you will be expected to provide regulatory and quality support and strategic regulatory guidance and information to clinical research projects. You will be expected to lead, develop and mentor the central Regulatory team in the company and provide expert guidance and cooperation to other key departments such as Business Development, Project Management and Clinical Operations. Reporting to the Vice President, Project Management, you will be a key member of the company Senior Management Worldwide.

We are searching for an experienced, ambitious and energetic person, able to undertake challenges. The desired person shall be open to cross cultures communication and cooperation, proactive and with a vision for Regulatory department development in a CRO.

Main Tasks of the Position

  • Develops and implements global regulatory strategies taking into consideration the overall development company objectives
  • Provides strategic regulatory support to other company departments, such as BD, PM, Clinical Operations etc
  • Participates in business development activities to grow Company’s clinical research business and takes part in new business development activities
  • Develops processes and assures implementation
  • Develops and manages Regulatory team
  • Performs other related duties as assigned.

Required Qualifications, Experience, Competencies

  • An undergraduate degree or its international equivalent in health sciences, medicine etc. from an accredited institution
  • At least 12 years industry experience, at least 7 years Regulatory experience and at least 5 years
  • Managerial experience required
  • Excellent knowledge of Regulatory environment
  • Proven track record in influencing and shaping optimal regulatory outcomes
  • A thorough understanding of EU clinical trials regulations
  • High ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
  • Ability to read and synthesize technical material and to prepare clear and concise written documents
  • Demonstrated experience in client service in the clinical research business
  • Demonstrated ability to form strong working relationships across functional boundaries and clients
  • Excellent communication skills in multicultural, multilingual environments
  • Knowledge of managing global multicultural teams
  • Highly organized and structured
  • High analytical skills
  • High ability to lead large strategic projects
  • Very strong strategic thinking and leadership abilities
  • Excellent management, negotiation, and advocacy skills
  • Demonstrated ability to motivate, lead, and grow a regulatory affairs team for optimum performance
  • Read, write and speak fluent English
  • Location – Europe

Benefits

  • Working with experienced and very professional and supportive team
  • Possibility to develop within the Company
  • Competitive remuneration
  • Flexible working time
  • Eligibility to the Company Bonus scheme
  • Benefits according to the country 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:

    Apply for job


    Max. file size: 2M