Regulatory Affairs Manager (Clinical Trials)

Recruit Shop Pty Ltd; London; On-site; GBP 50,000 - 90,000; Full time

Job summary

An innovative firm is seeking a Regulatory Affairs Manager to lead compliance for groundbreaking clinical trials. This pivotal role involves navigating complex regulations, advising project teams, and ensuring trials meet high standards of innovation and compliance. The successful candidate will have a strong background in regulatory affairs, particularly within clinical trials, and will work closely with global regulatory agencies. Join a forward-thinking organization dedicated to improving women's health through cutting-edge research and trial methodologies. If you're passionate about making a difference in healthcare, this is the opportunity for you.

Qualifications

• Significant regulatory affairs experience in clinical trials.
• Knowledge of UK and international regulations.
• Experience with innovative trial concepts.

Responsibilities

• Lead compliance with global regulatory agencies for innovative trials.
• Develop and manage regulatory processes for clinical trials.
• Advise project teams on trial design and compliance.

Skills

Regulatory Affairs

Clinical Trials

Compliance

Communication Skills

Negotiation Skills

Documentation

Relationship Management

Problem Solving

Education

Degree in Science or Healthcare

Post-graduate Qualification

Tools

IT Tools

Job description

Regulatory Affairs Manager (Clinical Trials)

Position Title: Program Manager for AI and Digital Technologies for Women's Health

Reporting Relationship: Program Director, Women's Health

Team: Women's Health

Type of Employment: Full-time

Employment Duration: 2 Year Fixed-term Contract

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 include platform, adaptive, and decentralized trials, utilizing novel methods of participant identification, recruitment, intervention delivery, and analysis.

Context of the Role:

The Regulatory Affairs Manager will join the Innovative Trials Hub and lead compliance with laws and regulations set by global regulatory agencies for innovative trials. Their expertise in regulatory affairs within clinical trials is essential for navigating the complex global regulatory landscape. They will advise researchers and project teams, including those from the Imperial Clinical Trials Unit (ICTU), to ensure trials are conducted innovatively and meet regulatory requirements.

The Role:

This global role, based in the TGI UK office within Project Operations, involves developing and managing regulatory affairs processes focused on innovative trials, ensuring compliance with relevant regulations, standards, and guidance.

The manager will work with global regulatory agencies to understand applicable regulations, monitor regulatory changes (e.g., revision of ICH GCP, FDA, Helsinki Declaration), and advise project teams on trial design, compliance, and logistics, especially in novel settings involving drugs, data, and devices.

This position is suited for an individual with significant regulatory affairs experience in clinical trials seeking a senior, independent role in a novel trial setting.

Reporting Relationships: The Regulatory Affairs Manager reports to the Director, Global Project Operations.

Duties and Key Responsibilities:

1. Provide advice on preparing regulatory documents and submissions to agencies such as TGA (Australia), FDA (USA), EMA (Europe), MHRA (UK), and CDSCO (India).
2. Collaborate with global agencies to address compliance challenges in delivering innovative trials involving drugs, devices, or data.
3. Engage with regulatory agencies regarding pre-submission strategies, novel trial designs, regulatory updates, and pathways.
4. Facilitate meetings with authorities and stakeholders to discuss submissions and compliance issues.
5. Interpret relevant regulatory guidelines and monitor regulatory environment changes.
6. Develop internal processes to enhance regulatory submission efficiency and compliance globally.
7. Communicate regulations, procedures, and policies to internal stakeholders.
8. Ensure all trials comply with applicable regulations and GCP standards.
9. Identify regulatory risks and propose mitigation strategies.
10. Analyze laws and regulations impacting trial activities.

As a Team Member:

• Participate in projects to improve processes, tools, and systems.
• Maintain personal development and meet performance objectives.
• Uphold organizational values of integrity, collaboration, and high ethical standards.
• Contribute ideas for process and system improvements.

Work, Health and Safety:

• Comply with WHS legislation and practices.
• Promote a safe environment for staff and visitors.

Skills, Knowledge, and Experience:

• Degree or equivalent in a related science or healthcare discipline.
• Experience in clinical trial regulatory affairs from academic, CRO, NHS, or pharmaceutical sectors.
• Knowledge of UK regulations, including EU Directive 2001/20/EC, UK Research Governance Framework, Clinical Trials Regulations 2004, GCP, Human Tissue Act, Data Protection Act, GDPR, and Mental Capacity Act.
• Understanding of regulations outside the UK (Australia, US, Europe, India).
• Knowledge of device regulation and ISO14155.
• Experience with regulatory submissions for UK and global trials.
• Ability to interpret regulations and advise on trial design and compliance.
• Skill in summarizing complex regulatory topics.
• Experience with innovative trial concepts (adaptive, platform, decentralized).
• Strong relationships with regulatory authorities and industry bodies.
• Excellent communication, negotiation, and relationship management skills.
• Proficiency in documentation and IT tools.
• Flexible, detail-oriented, motivated, and able to work independently.
• Willingness to travel.
• Post-graduate qualification or ongoing professional development.
• Experience with decentralized/innovative clinical trials.

Please note that the job description is not exhaustive, and additional duties may be assigned in line with key responsibilities.