Regulatory Affairs Manager (Clinical Trials)

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 and 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.

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.

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 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 Drugs 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.
• Develop and maintain positive communication and engagement with regulatory agencies regarding pre-submission 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 organisation’s 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 TGI’s Performance Management and Development Policy.
• Demonstrate commitment to TGI’s 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

You will be an established Regulatory Affairs professional, with significant experience of working in clinical trials in an industry setting.

Education

• Minimum tertiary qualification in medicine/pharmacy/life science.
• Relevant post-graduate qualifications would be well regarded.
• Current Good Clinical Practice qualification

Experience and Knowledge

• Excellent knowledge of clinical trial regulatory processes, regulations and guidelines (global experience preferred).
• Ability to read, understand, interpret and follow regulatory guidelines. 

• Knowledge of the governance and legislative framework for conducting clinical research studies, including Good Clinical Practice.
• Experience of working on the development of new concepts, techniques and standards
• A passion for regulatory affairs and clinical trials, with focus, energy, and desire to make a difference.

Skills & Abilities

• Ability to apply knowledge of Regulatory Affairs to the delivery of novel or innovative clinical trial designs e.g. adaptive, platform or decentralised trials.
• 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.
• 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.

• Strong problem-solving skills.
• Ability to work with minimal day-to-day supervision.
• 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.
• 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

• Experience with decentralized/innovative Clinical Trials.

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

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 world’s biggest killers: non-communicable 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 resource-poor 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 10,000 peer-reviewed publications and other academic outputs.

The Global Women’s 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, non-communicable diseases in pregnancy and women. It also addresses women-specific conditions, such as endometriosis and cervical cancer, and explores the intersection of women's health and environmental change.

What we do

• Lead world-class, large-scale clinical trials, epidemiological studies and health systems research to transform treatments and healthcare delivery.
• Look beyond single diseases, across the life course, to identify patient-centred approaches to care that can be implemented at scale.
• Develop low-cost, innovative solutions to global unmet needs.
• Drive our global impact through a program of research, advocacy, thought leadership and disruptive social entrepreneurship.