Cell and Gene Therapy Catapult: Regulatory Affairs Manager

Overview

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

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 stakeholdersCompile and submit regulatory submissions, ensuring that they are delivered to agreed time, cost and quality standardsTo support the development programmes in place in CGT Catapult, providing expert advice to ensure the programmes are developed in a way which meet regulatory and quality requirementsKey Responsibilities

With the Head of Regulatory Affairs and/or Senior Lead Regulatory Affairs, develop an agreed CMC/ regulatory strategy and implementation plan for each programmePrepare regulatory documents (briefing documents, GMO submissions, CTAs, INDs, amendments, safety reports, annual reports, etc.) to meet business needs and agreed time, cost and quality standardsTo liaise closely with relevant departments of CGT Catapult 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 requirementsEnsure appropriate regulatory due diligence is carried out on all incoming propositions and external facing proposalsMaintain up to date knowledge of development in regulations, guidelines, CMC, GCP and GMP requirements for cell and gene therapy productsDevelop 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 managementExperience

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 productsProven experience of working independently in the drafting and delivery of high-quality regulatory documentsSkills, Knowledge and Expertise

Highly motivated, pragmatic and practical to support the mission of the Cell and Gene Therapy Catapult to accelerate the development of a commercial cell and gene-based therapy industry in the UKDesire to establish a high-profile career within cell and gene sector and the personal drive to help push the sector to be a commercial successKnowledge of US regulatory frameworks (Advantageous)Working knowledge of EU GMP and tissues and cells legislation (Advantageous)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 therapyAbility to lead the quality and regulatory aspects of the development strategy for assigned CGT Catapult ProgrammesDemonstrable regulatory leadership of CTA /IND processes as well as experience of scientific advice meetings with Regulatory Authorities is an advantageProven ability to consistently deliver to time, cost and quality standardsCan be counted on to deliver tasks, planning effectively and managing time to cope with the unexpectedApplies technical expertise/practical experience and shares knowledge with others to continuously improve; provides opportunities to involve others in projects by listening, collaborating and influencing to create wider impactProposes solutions and seeks advice to gets things doneBuilds trust and credibility with others through clear communication, pursues and secure buy-in from a range of peopleUnderstands the importance of working together and aligns abilities and goals with those of the teamNavigates ambiguity well and learns from experiences; demonstrate resilience when coping with challengesActively seeks to understand, question and listen to others to improve effectiveness to benefit the team and divisionOpen to feedback and confident to deliver constructive feedback with the intent of learning and developing themselves and othersHigh level interpersonal, communication (oral and written) skills and emotional intelligenceA "roll your sleeves up" hands-on attitude towards varying work assignmentsProject ownership and pride in its deliveryAbility to work well under pressure, to work independently and to be able to take the initiative when completing tasksAmbitious, collaborative, drivenComfortable operating autonomously once goals and objectives are setAble to evaluate complex situations and find solutions for them in a professional mannerAccurate with strong attention to detailHigh degree of motivation, problem solving skills and innovative thinkingA positive attitude towards learning, personal and professional developmentKeeps up to date with professional knowledge, expertise and best practiceWillingness to travelEducation / Qualifications

Higher degree or at a minimum graduate in a life science ..... full job details .....