Regulatory Affairs Manager Clinical Trials

Innovative Trials Hub

The Innovative Trials Hub is a new global initiative within TGI aiming to create a team of experts to support the design delivery and analysis of innovative clinical trials. These will include platform adaptive trials decentralized trials and utilize novel methods of identifying & recruiting participants delivering trial interventions and conducting analyses.

Context of the Role

The Regulatory Affairs Manager will join the Innovative Trials Hub and will take the lead in ensuring compliance with the laws and regulations set forth by global regulatory agencies for innovative trials. Their significant expertise in regulatory affairs within clinical trials is essential for navigating the complex global regulatory landscape and acting as the expert in regulatory affairs in the innovative trial setting. They will be the lead for guiding & advising researchers & project teams (including those from Imperial Clinical Trials Unit (ICTU) to ensure that trials can be conducted in an innovative way and meet all necessary regulatory requirements.

The Role

The Regulatory Affairs Manager is a global role based in the TGI UK office within Project Operations responsible for leading the development and management of regulatory affairs processes focused on innovative trials ensuring compliance with all relevant regulations standards and guidance.

They work closely with the global regulatory agencies to understand the scope of all applicable regulations navigate the changing landscape of regulations (e.g. revision of ICH GCP FDA and Declaration of Helsinki) and will provide advice to project operations teams and researchers ensuring that new clinical trials can be conducted within the regulations.

This role would be ideal for an individual with significant regulatory affairs experience in clinical trials looking for a more senior independent role in a novel clinical trial setting.

Reporting Relationships

The Regulatory Affairs Manager reports to the Director Global Project Operations.

Duties and Key Responsibilities

• Provide advice and guidance to project operations teams on the preparation of clinical trial regulatory documents or submissions to relevant regional regulatory bodies such as Therapeutic Goods Administration (TGA) in Australia Food and Drug Administration (FDA) in the United States the European Medicines Agency (EMA) in Europe the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom and Central Standard Control Organization (CDSCO)in India.
• Work closely with global regulatory agencies to navigate the challenges of compliance with regulations specifically in the delivery of innovative trials utilising devices or data
• Develop and maintain positive communication and engagement with regulatory agencies regarding presubmission strategies novel trial designs revision of regulations and potential regulatory pathways to inform researchers around suitability of potential new trials.
• Facilitate meetings and communications with regulatory authorities and other stakeholders to discuss submission strategies and compliance issues.
• Examine identify and interpret relevant regulatory guidelines.
• Develop a deep understanding of new and existing regulations that may impact clinical trials maintain knowledge and track changes in the regulatory environment sharing updates promptly and effectively.
• Participate in the development and implementation of internal processes and systems to enhance the efficiency and quality of regulatory submissions and compliance ensuring processes and procedures are adequate to meet compliance with regulations globally.
• Explain regulations procedures and policies to all internal stakeholders as necessary ensuring the organisation has accurate guidance on regulatory compliance and clinical trial matters.
• Ensure all clinical trials are conducted in compliance with applicable regulatory requirements and Good Clinical Practice (GCP).
• Identify potential regulatory risks to clinical trial programs and propose mitigation strategies.
• Analyse and evaluate laws and regulations that apply to the process of determining the impact on the organisations activities.

As a Team Member:

• Participate in special projects to improve processes tools systems and organisation.
• Take responsibility for personal learning and development and for setting achievable and meaningful work objectives and managing personal targets meeting obligations of TGIs Performance Management and Development Policy.
• Demonstrate commitment to TGIs organisational values including performing to an exceptionally high ethical standard and focus on integrity collaboration and teamwork in all efforts.
• Contribute ideas and experiences so that improve processes tools systems and organisation.

Work Health and Safety

• Comply with Work Health and Safety legislation and operate in accordance with established Occupational Health and Safety practice and procedures at TGI.
• Promote and contribute to a safe secure environment for staff and visitors.

Skills Knowledge and Experience

Essential

• Degree or equivalent experience in a related science or healthcare discipline
• Relevant experience in clinical trial regulatory affairs from within academic CRO NHS or pharmaceutical environments
• Sound knowledge of UK clinical trial regulations including: the EU Directive 2001/20/EC the Department of Health Research Governance Framework for Health and Social Care 2017 the Medicines for Human Use (Clinical Trials) Regulations 2004 and its amendments Guidelines for Good Clinical Practice (GCP) the Human Tissue Act 2004 Data Protection Act 2000 GDPR 2018 and the Mental Capacity Act 2005
• Knowledge of the clinical trial regulations in countries outside of the UK e.g. Australia United States Europe and India
• Sound knowledge of device regulation and ISO14155
• Experience of making regulatory submissions for clinical trials in the UK and globally including experience of providing advice and guidance to project teams on content and structure of regulatory document submissions.
• Ability to interpret applicable regulations and provide advice to project operations teams on trial design compliance and logistics especially in novel settings involving data and devices.
• Ability to summarise complex topics updates to regulations and guidance into easily digestible formats.
• Experience of working on the development of new concepts techniques and standards
• Ability to apply knowledge of Regulatory Affairs to the delivery of novel or innovative clinical trial designs e.g. adaptive platform or decentralised trials.
• Strong interaction and relationships with regulatory authorities and relevant Industry Bodies.
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organisation.
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
• Excellent written & verbal communications skills.
• Ability to interact professionally with local regional and global team members.
• Ability to work with minimal daytoday supervision with strong problemsolving skills
• Good IT skills particularly in the use of Web applications and MS Office applications.
• Flexible approach to working and a desire to develop knowledge.
• Excellent attention to detail.
• Highly motivated with the ability to influence and inspire others with the ability to see the big picture yet still focus on detail.
• Ability to be flexible and adaptable in the face of changing organisational priorities and ambiguous environments.
• Ability to travel.

Desirable

• Postgraduate qualification or evidence of continuing professional development
• Experience with decentralized/innovative Clinical Trials.

Please note that job descriptions cannot be exhaustive and the postholder may be required to undertake other duties which are broadly in line with the above key responsibilities.

For a more detailed Position Description please click here

Applications close on Sunday 11 May 11.59pm GMT. We reserve the right to close this advertisement early should we find a successful candidate.

For any queries in relation to this position please contact Jo Gambell Operations Manager Clinical Trials Centre for Operations and Research Excellence via email

About The George Institute for Global Health

The George Institute for Global Health was established in 1999 with a mission to improve the health of millions of people worldwide especially those in underserved populations by challenging the status quo and using innovative approaches to prevent and treat the worlds biggest killers: noncommunicable diseases and injury.

With offices in the United Kingdom (UK) Australia China and India our 700 staff members support 245 active projects and clinical trials over 50 countries complemented by an additional 400 staff in our social enterprises. We focus on the global health challenges that cause the greatest loss of life the greatest impairment of life quality and the most substantial economic burden particularly in resourcepoor settings.

Together with our academic partners Imperial College London in the UK UNSW Sydney in Australia and Manipal Academy of Higher Education in India we work with a global network of collaborators undertaking clinical population and health systems research.

Our experts are among the most cited globally bestowed accolades for excellence and innovation and regularly participate in policy fora. Our research is published in leading academic journals referenced in policy documents and recognised for its excellence innovation and impact. We are designated a WHO Collaborating Centre (WHO CC) for Injury Prevention & Trauma Care and a WHO CC for Population Salt Reduction. Since 1999 we have raised more than $1 billion for research and produced over 10000 peerreviewed publications and other academic outputs.

The Global Womens Health Program was established in 2018. With staff and projects across all TGI offices the program is led by Professor Hirst in the UK office. The program conducts research and policy work that focuses on sex and gender differences in health outcomes noncommunicable diseases in pregnancy and women. It also addresses womenspecific conditions such as endometriosis and cervical cancer and explores the intersection of womens health and environmental change.

What we do

• Lead worldclass largescale clinical trials epidemiological studies and health systems research to transform treatments and healthcare delivery.
• Look beyondsingle diseases across the life courseto identify patientcentred approaches to care that can be implemented at scale.
• Develop lowcost innovative solutions to global unmet needs.
• Drive our global impact through a program of research advocacy thought leadership and disruptive social entrepreneurship.

For more information about The George Institute visit