Regulatory Affairs Manager (Clinical Trials)

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 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 utilising drugs, devices or data.
• 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

• 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 drugs, 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 day-to-day supervision with strong problem-solving 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.
• Post-graduate qualification or evidence of continuing professional development.
• 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.