Regulatory Affairs Manager

The Key Purpose of the role is to:

· Implement optimal regulatory strategies for each programme in agreement with the Head of Regulatory Affairs, Chief Clinical Officer (CCO) and key stakeholders

· Compile and submit regulatory submissions, ensuring that they are delivered to agreed time, cost and quality standards

· To support the development programmes in place, providing expert advice to ensure the programmes are developed in a way which meet regulatory and quality requirements

Key Accountabilities:

· With the Senior Regulatory Affairs Manager and/or Head of Regulatory Affairs, develop an agreed CMC/ regulatory strategy and implementation plan for each programme

· Prepare regulatory documents (briefing documents, GMO submissions, CTAs, INDs, amendments, safety reports, annual reports, etc.) to meet business needs and agreed time, cost and quality standards

· To liaise closely with relevant departments of and external Collaborators to ensure proposed developments (manufacturing and analytical) are fit for purpose and suitably planned whilst ensuring the development programme will meet regulatory and quality requirements

· Ensure appropriate regulatory due diligence is carried out on all incoming propositions and external facing proposals

· Maintain up to date knowledge of development in regulations, guidelines, CMC, GCP and GMP requirements for cell and gene therapy products

· Develop and maintain constructive working relationships with regulatory agency and health authority contacts, contributing to strategies to influence regulators as required towards appropriate risk evaluation and management

Experience:

· Approximately 3-5 years’ or more regulatory affairs experience, ideally with 1-2 years in a cell and/or gene therapy environment or, at a minimum, with some experience in the regulation of biologic or biotech products

· Proven experience of working independently in the drafting and delivery of high quality regulatory documents

Knowledge / Skills / Competencies:

· Highly motivated, pragmatic and practical to support the mission of the company to accelerate the development of a commercial cell and gene-based therapy industry in the UK

· Desire to establish a high profile career within cell and gene sector and the personal drive to help push the sector to be a commercial success

· Proven ability to evaluate and implement efficient regulatory strategies and manage complex regulatory issues including areas of biotechnology, biological therapies and preferably, cell and gene therapy

· Ability to lead the quality and regulatory aspects of the development strategy for assigned Programmes

· Demonstrable regulatory leadership of CTA /IND processes as well as experience of scientific advice meetings with Regulatory Authorities is an advantage

· Proven ability to consistently deliver to time, cost and quality standards

· High level interpersonal, communication (oral and written) skills and emotional intelligence

· A “roll your sleeves up” hands-on attitude towards varying work assignments

· Resilient, with the ability to manage multiple and varied tasks and prioritise workload within a fast-paced environment

· Flexible and pragmatic, able to learn quickly and respond flexibly to project needs and priorities

· Project ownership and pride in its delivery

· Flexibility towards work assignments and new learning

· Ability to work well under pressure, to work independently and to be able to take the initiative when completing tasks

· Ambitious, collaborative, driven

· Comfortable operating autonomously once goals and objectives are set

· Able to evaluate complex situations and find solutions for them in a professional manner

· Accurate with strong attention to detail

· Ability to quickly establish credibility and build rapport and trust

· Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives and to respond to a wide range of customer and management needs

· Proven diplomacy skills with diverse groups of internal and external stakeholders

· High degree of motivation, problem solving skills and innovative thinking

· A good team player with a hands-on approach, and adaptable to new challenges

· A positive attitude towards learning, personal and professional development

· Keeps up to date with professional knowledge, expertise and best practice

· Willingness to travel

In addition, one or a combination of the following are also highly desirable:

· Experience of registration of cell and gene therapies for clinical trial throughout the EU/UK and US

· Experience of EU centralised procedures such as ATMP classification, paediatric investigational plans and orphan drug applications

· Knowledge of US, Japanese, Canadian or Chinese regulatory frameworks

· Working knowledge of EU GMP and tissues and cells legislation

· Experience of regulatory components of device development and registration an advantage

· Experience in playing a role in early phase research and development programmes with a view to inclusion in regulatory submissions

Education / Qualifications:

· Higher degree or at a minimum graduate in a life science subject.