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| Job Location | London |
| Education | Not Mentioned |
| Salary | Competitive salary |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent, full-time |
Head of Regulatory Affairs, ATMP, Cell Therapy, Gene Therapy, ODD, PIP, CTA, Regulatory Strategy Your new companyThis UK-based research and innovation centre are looking for a Head of Regulatory Affairs to join their tight-knit development team. The company specialise in ATMP work across highly advanced Cell and Gene therapies in early stage development through to manufacturing. They are the leaders of ATMP work across the UK and this role will be based in Central London.Your new roleAs head of Regulatory Affairs, you will be responsible for all-related Regulatory processes within the company. This includes working across Regulatory strategy development and implementation, leading and preparing highly technical documentation submissions, and maintaining a strong knowledge across relevant Regulatory guidelines. This role will be reporting into the Chief Clinical Officer and managing a strong team of Regulatory Affairs professionals. You will be involved across the business working with clinical, manufacturing, and other relevant departments. The ideal candidate will be a highly experienced Regulatory Affairs professional, with a vast skill set in the Advanced Therapy space across early development processes.What youll need to succeedLead all Regulatory Strategy development in Cell & Gene Therapy related ATMPsLine management of Regulatory Affairs teamWork with external stakeholders and manage client relationshipsSupport updates in regulation across EU, UK and FDA requirementsEarly development process submissions: ODDs, PIPs, CTAs, INDs/NDAs, Scientific AdviceWork directly alongside CCO and other relevant internal departmentsWhat youll get in returnYou will get the opportunity to work and manage highly technical Regulatory processes in early development across ATMPs. You will additionally get to work across a wide variety of products and expand your network in ways incomparable to most. Finally, you will be treated with a competitive package and benefits to match. What you need to do nowIf youre interested in this role, click apply now to forward an up-to-date copy of your CV, or call us now.If this job isnt quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. Required skills
Keyskills :
CTA Gene Therapy PIP Cell Therapy ODD Regulaty Strategy ATMP Head of Regulaty Affairs