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Regulatory Science Officer

Imperial College London

Location: London
Salary: £43,309 to £52,558 per annum
Hours: Full Time
Contract Type: Fixed-Term/Contract
Placed On: 11th December 2023
Closes: 22nd January 2024
Job Ref: NAT01598
 

Location: South Kensington Campus

Job Summary

We are seeking to recruit a Regulatory Science Officer to undertake the regulatory aspects of the Transmission Zero Programme (https://www.transmissionzero.org/) as it expands the range of its activities and prepares for regulatory approval to eventually test genetic malaria control candidate interventions in the malaria endemic setting. Critical to the project’s success is delivering and articulating scientifically credible, accessible, evidence-based data to address its risk assessment and regulatory needs.

You will play a critical role in enabling the project to achieve key milestones and its ultimate objectives by: (i) engagement with academic, regulatory and policy organisations to develop and clarify the evidence-based requirements for the project (ii) contribute to and translate product risk assessments as well as regulatory requirements into study design and regulatory science practices within the project and, (ii) Securing the regulatory studies, data and evidence needed to address the risk questions and regulatory needs of regulatory applications from the project and articulating these doe regulatory documents.

You will work directly with the academic co-directors of Transmission Zero as well as the African partner teams at IHI and NIRM, the regulatory affairs teams in other gene drive projects as well as external consultants. You will ensure that regulatory science output is fully aligned with Transmission Zero’s regulatory strategy and will be a major driver and source of impetus to make sure that regulatory aspects of the project are progressing at the desired pace.

Duties and responsibilities

  • You will be responsible for building professional relationships both internally and with external bodies, such as national and international organizations with a focus on regulatory science and risk assessment policy.
  • You will be expected to interpret regulatory requirements, standards or guidance documents of international agencies and target countries, and review and determine whether any changes in such guidance that impact on regulatory science should be adopted swiftly and effectively by the project.
  • You will ensure regulatory science activities are aligned with the regulatory strategy of the project and informed by any developments in regulatory affairs.
  • You will manage the timely delivery of the portfolio of regulatory studies that are required for the project’s regulatory documents and submissions.
  • You will ensure regulatory studies are conducted in compliance with regulatory requirements, guidelines, and protocols, including via the development of and adherence to internal procedures, templates and tools for effective regulatory science studies and reports. 

Essential requirements

  • You should hold a MRes or PhD in life sciences research, extensive training and/or experience in research and/or regulatory environment and use of data.
  • You should have extensive experience and expertise in understanding the use of regulatory science to support the application of novel technologies and have experience in a multi-disciplinary environment with the ability to translate scientific and technical issues into assessable communication for both experts and non-practitioners/non-experts.
  • You should have advanced knowledge of regulatory science to support delivery of a comprehensive package of studies that address risk assessment and regulatory needs of GM applications. 

Further Information

The post is available full-time, fixed term until 31 December 2026. You will be based at the South Kensington Campus.

Should you require any further details on the role please contact: Dr Nikolai Windbichler, n.windbichler@imperial.ac.uk or Professor George Christophides, g.christophides@imperial.ac.uk

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