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Director Regulatory Affairs

14 September 2018

If you are inspired by developing your career in a stimulating environment where you can make a profound difference to the healthcare of patients, my client can offer exceptional careers for exceptional people. Based on an established Bioscience campus in Cambridge, you will have the opportunity to work with smarter science, unique technologies and highly experienced scientific leaders. 

My client is looking for Director of Regulatory Affairs to provide strategic input and guidance for new antibodies that are in the development stage. This is a fantastic opportunity to join a developing business, with an exciting portfolio and pipeline.

Key Responsibilities:

  • Provide strategic regulatory affairs guidance for the development of new antibodies that are in development
  • Regulatory affairs activities with particular focus on regulatory compliance for clinical trials
  • Develop or establish relationships with regulatory authorities; industry community and partners
  • Identify and liaise with external contractors related to regulatory compliant work 
  • Contribute to a range of project teams
  • Contribute to organising and scheduling teamwork to ensure that projects meet agreed regulatory procedural deadlines

Qualifications and Experience:

  • Batchelor of Science (BSc) with a second degree preferred
  • Significant industry/biotech experience of early-phase clinical trials
  • Expert level of knowledge in regulatory affairs
  • Experience with FDA submissions would be highly advantageous along with strong US market knowledge
  • Experience within Rare Disease would be beneficial
  • Exceptional communication, collaboration, influencing and leadership skills

Can you see yourself being part of a company that celebrates diversity and believes that better thinking and decisions come from wider experience? If the answer is yes and you have a desire to be an integral part of a dynamic team, we would be keen to hear from you. In the first instance, please send your CV to kirsty@regulatoryprofressionals.com or call Kirsty on 01189 522 797. We endeavour to come back to you within 24 hours of CV submission.

KeyWords: Regulatory, Regulatory Director, Antibodies, Biologic, Regulatory Strategy, Early Phase, FDA, Cambridge.