Clinical Research Associate ofertas em Itália

We are looking for a Regulatory Scientist to lead our Genetic Technologies Regulatory function within the Innovation, Productivity and Science Division of Defra. The Genetic Technology Regulatory Team are responsible for regulating the deliberate release of genetically modified organisms (GMO) and precision bred organisms (PBO). This is an exciting time for Engineering Biology, with inclusion as a sub-sector in the Industrial Strategy, and a focus for the Government Chief Scientist. The applications for PBO and GMO span wider than agriculture, and the remit of Defra with potential benefits in health care, defence, circular economy, transport and energy. Unlocking genetic codes across all organisms and using them to solve many of our challenges has significant potential for growth opportunities but this needs to be regulated proportionately. The Regulators lead strategic engagement with other regulators both domestically and internationally, to align regulations and innovation and work in partnership to deliver common priorities. The Genetic Technology Regulation team support the deliberate release of novel and potentially transformative GMO and PBO products to optimise their route to market. They act to ensure Defra can play its role as an enabler for delivering growth and supporting the Government priorities supporting UK Engineering Biology and how to harness the critical technologies outlined in the UK Science and Technology Framework. The team are responsive to emerging areas on innovation, problem solving and driving the regulatory policy development, providing technical subject matter expertise while focusing on the environment and health. This enables team members to develop expertise across a range of regulatory areas, giving significant personal development opportunity.

• Provide specialist knowledge and insight as one of the team's specialists in modern biotechnology product regulation, to apply regulatory expertise and knowledge to support the Genetic Technologies Regulation function providing expert regulatory advice to external stakeholders / requesters, ensuring that the advice adds value to the information that is currently available in the public domain.
• Support the Head of Genetic Technologies to drive forward the development of cross-cutting strategy, policy and guidance, working with other technical experts, contributing to Defra's wider innovation strategy by informing decisions on the case for change through use of evidence, providing advice and briefings to senior leaders on a variety of matters relating to the regulation of deliberate release of GMO and PBO. This will include playing a leading role in developing regulatory pathways that can optimise the development of new innovative products and technologies.
• Develop and build good working relationships across Defra and related organisations with a strong appreciation of the wider roles and remits which ensures coordination of activities. Appreciate different stakeholder views including industry, academia and patients, bringing different perspectives together to understand regulatory and technical challenges to maximise the impact of our work for the benefit of all.
• Monitor the broader regulatory landscape relating to innovative product and regulatory environment in order to provide advice and insight to steer, prioritise, and maximise the impact of Defra's activities. This will include preparing and presenting high-quality briefing and guidance documents, communicating complex issues into clear and concise policy recommendations, to advise senior officials and support key decision making.
• Lead and direct the Genetic Technology Regulations Team ensuring statutory requirements are met on time and to specified quality.
• Set the standard for the team for advice to ministers and in approaches to record keeping to meet statutory requirements and legal challenge.
• Engagement and leadership with relevant OGDs, sector and industry leads and international regulators.
• Speak with authority on GT regulations and underpinning science.
• Lead and build engagement with a wide range of stakeholders including policy and evidence teams, OGDs, industry, academia and stakeholders including at an EU international level on complex technical issues to inform statutory requirements and/or policy interventions.
• Lead on communication and translation of evidence and regulatory framework to policy areas across AFC and the wider department and in discussions with other government departments and interested parties as required.
• Take a corporate lead beyond immediate work area when required.

• A high level of qualification (PhD-level or equivalent experience) will be required.
• Strong scientific expertise in genetic technologies.
• Proven leadership and influencing capabilities in a specialised field, with excellent science communication skills.
• Ability to provide briefing and support to senior leadership and Ministers in their specialist field, often providing a leading expert voice and advice on high-risk policy and regulatory priorities.
• A high level of management skills and policy understanding.

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