KC227 - Associate Director, Regulatory Affairs

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Posted: 08/08/2019 12:15
Start Date: Not Available
Salary: Competitive
Location: Babraham Research Campus, Cambridge, UK
Level: Administrative
Deadline: 06/09/2019 23:59
Hours: 35.00
Benefits: Excellent range of benefits
Job Type: Permanent

Kymab is a clinical-stage biopharmaceutical company developing a deep pipeline of novel antibody-based therapies in a broad range of indications. The Company generates its product candidates using its proprietary, integrated platforms collectively called IntelliSelect®. Kymab’s platforms have been designed to maximize the diversity of human antibodies produced in response to immunization with antigens. Selecting from a broad diversity of fully human antibodies allows for the identification of antibodies with optimal drug-like properties.

Reporting to the Vice President, Regulatory Affairs, we are looking to recruit an Associate Director of Regulatory Affairs to help drive our rapid development of new therapeutic antibodies initially in inflammation and immuno-oncology.  This role will provide exposure to regulatory affairs including in the US, EU and Taiwan.

Key responsibilities:

  • Provide regulatory affairs guidance and proactive, practical hands-on input to achieve the required authorisations for national and multi-national clinical trials
  • Regulatory affairs activities with particular focus on regulatory compliance for clinical trials
  • Develop or establish working relationships with third party partners in industry as appropriate to Kymab’s clinical research programmes and business plans
  • To liaise with external contractors related to regulatory compliant work carried out on behalf of Kymab and ensure appropriate standards are met
  • To communicate progress and identify risks and issues arising on regulatory issues to the Vice President, Regulatory Affairs and the Development Clinical Trial Team
  • Contribute to a range of project teams, as required
  • Contribute to organising and scheduling teamwork to ensure that projects meet agreed regulatory procedural deadlines

Job requirements:

  • Bachelor of Science (BSc) with a second degree preferred
  • Significant industry/biotech experience of early-phase clinical trials
  • Expert level of knowledge in pre-authorisation regulatory affairs
  • Knowledge of Development Good Practices (GxP)
  • Exceptional communication, collaboration and influencing skills
  • Maintain a high standard of professionalism when representing the Company, both internally and externally
  • Excellent personal integrity, energy and drive

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