Regulatory Affairs Specialist, Clinical Trials

Closing Date: Thursday 30 May at 5pm GMT.

REPORTING RELATIONSHIP: Director Global Project Operations

TEAM/PROGRAM: Academic Project Operations

FULL TIME EQUIVALENT: 1 FTE

CAREER STEP: Specialist (Projects)

EMPLOYMENT DURATION: Per contract (2-3 years)

START DATE: ASAP

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.

For more information about The George Institute, visit www.georgeinstitute.org.uk

Context of the Role  

The Regulatory Affairs Specialist is at the forefront of ensuring compliance with the laws and regulations set forth by regulatory agencies. Their expertise is essential for navigating the complex landscape of clinical trials guiding and advising the researchers, project teams including, Imperial Clinical Trials Unit (ICTU), to ensure that research studies meet all necessary regulatory requirements.

The Role

The Regulatory Affairs Specialist is a global role based in the TGU UK office within Project Operations, ensuring that clinical trials adhere to strict regulatory guidelines, which are in place to protect the rights and welfare of study participants. They work closely with the project operations team and researchers, providing advice and guidance to secure all necessary approvals and documentation before the commencement of a clinical trial.

The Regulatory Affairs Specialist is responsible for developing and managing regulatory affairs processes with a strong focus on decentralized trials, ensuring compliance with all relevant regulations, standards, and guidance, particularly in maintaining regulatory documentation.

Reporting Relationships

The Regulatory Affairs Specialist reports to the Director, Global Project Operations.

Duties and Key Responsibilities

• Identify and guide the preparation and submission of documentation to relevant region 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.
• Maintain knowledge and track changes in the regulatory environment, sharing updates promptly and effectively.
• Ensure all clinical trials are conducted in compliance with applicable regulatory requirements and Good Clinical Practice (GCP).
• Examine, identify, and interpret relevant regulatory guidelines. Provide informed, accurate regulatory guidance in compliance and clinical trial matters.
• Explain regulations, procedures, and policies to all internal stakeholders as necessary.
• Facilitate meetings and communications with regulatory authorities and other stakeholders to discuss submission strategies and compliance issues.
• Identify potential regulatory risks to clinical trial programs and propose mitigation strategies.
• Participate in the development and implementation of internal processes and systems to enhance the efficiency and quality of regulatory submissions and compliance.
• Maintain a deep understanding of new and existing regulations that may impact clinical trials.
• Ensure processes and procedures are adequate to meet compliance with regulations globally.
• Advise on matters related to regulatory processes and compliance.
• Oversee the planning, coordination, and management of regulatory documentation activities.
• Analyse and evaluate laws and regulations that apply to the process of determining the impact on the organisation’s activities.
• Compile and oversee the maintenance of regulatory documentation databases or systems.
• Provide advice and guidance on the preparation of regulatory documents or submissions.
• Develop and maintain healthy communication with regulatory agencies regarding pre-submission strategies, compliance test requirements, potential regulatory pathways, or clarification, and follow-up on submissions still under review.
• Work closely with regulatory agencies to navigate the challenges of compliance with regulations specifically in the delivery of decentralised trials.
• Provide training and support to project teams and regional offices on regulatory requirements and submission processes.

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 should be an established Regulatory Affairs professional in Clinical Trials with industry experience.

Education

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

Experience and Knowledge

• Excellent knowledge of regulatory processes, regulations and guidelines.
• Ability to read, understand, interpret and follow regulatory guidelines. 
• A passion for regulatory affairs, focus, motivation and desire to make a difference.
• Knowledge of the governance and legislative framework for conducting clinical research studies, including Good Clinical Practice.

Skills & Abilities

• Expert knowledge of Regulatory Affairs while contributing to 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.
• 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 decentralised 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.

How to apply:

Please send your CV and cover letter explaining why you would be suited to, and successful in this role to Anna Willis: recruitment@georgeinstitute.org.uk (via the ‘Apply’ button above) by 5pm GMT on Thursday 30 May 2024.