KC232 - Director, Regulatory Affairs

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Posted: 10/09/2019 11:32
Start Date: Not Available
Salary: Competitive
Location: Babraham Research Campus, Cambridge, UK
Level: Senior Management
Deadline: 11/10/2019 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 a highly motivated Director, Regulatory Affairs to provide strategic 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 Duties/Responsibilities:

  • Provide strategic regulatory affairs guidance for the development of new drug candidates 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 relationships with regulatory authorities; industry community and partners in industry as appropriate to Kymab’s programmes and business plans

  • To identify, select and 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/or the Development Project Team as appropriate

  • 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

Education & Experience:

  • Bachelor of Science (BSc) with a second degree preferred

  • Significant industry/biotech experience of early-phase clinical trials

Skills & Knowledge:

  • Expert level of knowledge in regulatory affairs

  • Knowledge of Development Good Practices (GxP)

  • Exceptional communication, collaboration, influencing and leadership 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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