Regulatory Affairs Manager (12-15 Month FTC)

JR United Kingdom; London; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading company in the biotechnology sector is seeking a Regulatory Affairs Manager for a 12-15 month fixed-term contract. The role involves implementing regulatory strategies, preparing submissions, and ensuring compliance with quality standards. Ideal candidates will have 3-5 years of experience in regulatory affairs, particularly within the cell and gene therapy field, and a strong understanding of regulatory requirements.

Qualifications

• 3-5 years regulatory affairs experience, ideally in cell/gene therapy.
• Experience in drafting high-quality regulatory documents.
• Knowledge of US regulatory frameworks is advantageous.

Responsibilities

• Implement regulatory strategies and compile submissions.
• Prepare regulatory documents to meet business needs.
• Liaise with departments to ensure compliance with regulations.

Skills

Regulatory Affairs

Communication

Problem Solving

Attention to Detail

Education

Higher degree in life sciences

Job description

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Regulatory Affairs Manager (12-15 Month FTC), London

Client: Cell and Gene Therapy Catapult

Location: London, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Views:

1

Posted:

23.05.2025

Expiry Date:

07.07.2025

Job Description:

The Regulatory Affairs Manager at CGT Catapult will act as a regulatory representative for CGT Catapult programmes.

• Implement optimal regulatory strategies for each programme in agreement with the Head of Regulatory Affairs/Senior Lead Regulatory Affairs, Chief Clinical Officer (CCO), and key stakeholders.
• Compile and submit regulatory submissions, ensuring timely delivery within budget and quality standards.
• Support development programmes at CGT Catapult by providing expert regulatory advice to meet regulatory and quality requirements.

Key Accountabilities:

• Develop regulatory strategies and implementation plans for each programme in collaboration with the Head of Regulatory Affairs and/or Senior Lead Regulatory Affairs.
• Prepare regulatory documents (briefing documents, GMO submissions, CTAs, INDs, amendments, safety reports, annual reports, etc.) to meet business needs and standards.
• Coordinate with relevant departments and external collaborators to ensure proposed developments are fit for purpose and compliant with regulatory requirements.
• Conduct regulatory due diligence on incoming propositions and external proposals.
• Maintain up-to-date knowledge of regulations, guidelines, CMC, GCP, and GMP requirements for cell and gene therapy products.
• Build and maintain relationships with regulatory agencies and health authorities, contributing to strategies that influence regulators as needed.

Experience:

• Approximately 3-5 years or more in regulatory affairs, with 1-2 years in cell and/or gene therapy or biologics regulation.
• Experience in drafting and delivering high-quality regulatory documents independently.
• Motivated, pragmatic, and aligned with the mission to accelerate cell and gene therapy development in the UK.
• Knowledge of US regulatory frameworks and EU GMP and tissues and cells legislation is advantageous.
• Proven ability to manage complex regulatory issues in biotechnology, biological therapies, and cell and gene therapy.
• Leadership in regulatory processes such as CTA/IND and scientific advice meetings.

Qualifications:

• Higher degree or graduate in a life science subject.

CGT Catapult promotes diversity and inclusion, having received bronze accreditation from Inclusive Employers in 2024.