Cell Therapy Regulatory Expert

3 weeks ago


London, Greater London, United Kingdom Northreach Full time
Join Our Team

We are seeking a highly skilled Regulatory CMC Specialist to join our dynamic team in London.

This is an exciting opportunity to contribute to cutting-edge treatments in a fast-evolving field. As a key member of the regulatory affairs team, you will be responsible for ensuring the highest standards of quality and compliance in the development and submission of cell therapy and ATMP products.

Key Responsibilities:

  • Develop and implement CMC regulatory strategies tailored to cell therapy and ATMP products.
  • Prepare and review high-quality CMC documentation for regulatory submissions.
  • Cross-functional collaboration with manufacturing, quality assurance, R&D, and clinical teams.

Requirements:

  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, Cell Biology, or related sciences.
  • Minimum of 3–5 years' experience in a Regulatory CMC role, with direct experience in cell therapy, gene therapy, or ATMPs.
  • In-depth understanding of regulatory requirements for ATMPs.

Salary: £100,000 - £130,000 per annum

Benefits:

  • Competitive salary and benefits package.
  • Flexible hybrid working environment.
  • Opportunity to work on transformative therapies.
  • Professional development opportunities.
  • Inclusive and collaborative work culture.


  • London, Greater London, United Kingdom Northreach Full time

    Job Description:We are looking for a Cell Therapy Regulatory Expert to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with global regulatory requirements for ATMPs, including gene therapies, tissue-engineered products, and somatic-cell therapies.About the Job:Develop and implement CMC regulatory...


  • London, Greater London, United Kingdom Orchard Therapeutics Full time

    As a Regulatory Scientist in Cell and Gene Therapy, you will play a critical role in ensuring that our products meet the highest standards of quality and regulatory compliance.You will be responsible for providing expert review and approval of executed batch records, test records, and associated documentation for release of LVVs and plasmids used in their...


  • London, Greater London, United Kingdom Ecm Selection Full time

    Job DescriptionAs a Cell Therapy Manufacturing Expert, you will play a crucial role in the development and manufacturing of cell-based therapies. Your expertise in bioprocessing engineering and cell biology will enable you to design and optimize manufacturing processes, ensuring scalability and consistency.You will work closely with cross-functional teams to...

  • Cell Therapy Expert

    3 weeks ago


    London, Greater London, United Kingdom Northreach Full time

    Job TitleWe are seeking a skilled Cell & Gene Therapy Scientist to join our team at Northreach.This role involves close collaboration with cross-functional teams within our Manufacturing operations, focused on pioneering Treg therapies.The ideal candidate will have strong understanding of immunology and cell therapy, expertise in cell-based techniques,...


  • London, Greater London, United Kingdom Orchard Therapeutics Full time

    Why Join Us:At Orchard Therapeutics, we are committed to transforming the lives of patients with rare disorders through innovative gene therapies.This role offers the opportunity to join a dynamic team of experts in the field of analytical development and contribute to the development of new treatments for patients.The estimated salary for this position is...


  • London, Greater London, United Kingdom Northreach Full time

    Job DescriptionWe are seeking a highly skilled and detail-oriented Regulatory CMC Specialist with expertise in cell therapy and ATMP to join our dynamic regulatory affairs team. This is an exciting opportunity to contribute to cutting-edge treatments in a fast-evolving field.Regulatory Documentation and Submissions:Prepare and review high-quality CMC...


  • London, Greater London, United Kingdom Orchard Therapeutics Full time

    Job Title: Cell and Gene Therapy Method DeveloperLocation: London, UKSalary: £55,000 - £75,000 per annumAbout the JobThis role offers a unique opportunity to contribute to the development of innovative gene therapies at Orchard Therapeutics. As a Cell and Gene Therapy Method Developer, you will be responsible for designing, developing, and qualifying...


  • London, Greater London, United Kingdom Northreach Full time

    We are seeking a highly skilled and detail-oriented Regulatory CMC Specialist with expertise in cell therapy and ATMP to join our dynamic regulatory affairs team. This is an exciting opportunity to contribute to cutting-edge treatments in a fast-evolving field.


  • London, Greater London, United Kingdom Barrington James Limited Full time

    About this role:You will be responsible for leading the planning, implementation, and execution of clinical trials in cell and gene therapy from Phase I through Phase III. This will involve collaborating with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to ensure alignment of clinical operations with...


  • London, Greater London, United Kingdom Pharma Search Full time

    **Company Overview**Our client, a leading global pharmaceutical company, is committed to driving innovative research in medicine. With 175 years of outstanding history, they have always been at the forefront of novel and leading R&D, investing heavily in the identification, development, and delivery of innovative solutions to improve the treatment of...


  • London, Greater London, United Kingdom Northreach Full time

    We are seeking a highly skilled Regulatory CMC Specialist to join our dynamic regulatory affairs team at Northreach.This is an exciting opportunity to contribute to cutting-edge treatments in the fast-evolving field of advanced therapies.As a Regulatory CMC Specialist, you will play a critical role in ensuring compliance with global regulatory requirements...


  • London, Greater London, United Kingdom Northreach Full time

    About Our ClientOur client is a leading organisation in the cell & gene therapy sector, dedicated to improving healthcare outcomes through innovative research and development. They are seeking a highly skilled Senior Research Associate to join their Process & Analytical Research team.Job DescriptionThe successful candidate will be responsible for developing...


  • London, Greater London, United Kingdom Pharma Search Full time

    Redefining Medicine through InnovationPharma Search is a leading Global Pharmaceutical Company driving innovation and improving human lives.With a rich history of innovation spanning 175 years, we have always been at the forefront of novel R&D, investing in identifying, developing, and delivering innovative solutions to treat diseases.We are now investing...


  • London, Greater London, United Kingdom Pharma Search Full time

    Cell and Gene Therapy Research OpportunitiesWe are seeking a highly skilled Delivery Head to lead our Cell and Gene Therapy group, driving innovative research and development to improve treatment outcomes.As a leading Global Pharmaceutical Company, we have invested heavily in this area, with a commitment to pioneering change and delivering cutting-edge...

  • CMC Regulatory Expert

    2 weeks ago


    London, Greater London, United Kingdom Northreach Full time

    Northreach's Vision:We aim to be a leader in developing innovative treatments for patients worldwide.To achieve this goal, we are looking for a talented Advanced Therapy Specialist to join our team.About the Job:The successful candidate will be responsible for preparing and reviewing high-quality CMC documentation for regulatory submissions.This includes...


  • London, Greater London, United Kingdom RBW Consulting Full time

    Job DescriptionR BW Consulting is partnering with a UK-based biotech company to find an experienced Freelance Clinical Project Manager for their Oncology & Cell Therapy projects.Key Tasks:Manage clinical trials from start to finish, ensuring quality and timeliness.Develop and implement project plans, budgets, and timelines to meet business...


  • London, Greater London, United Kingdom Apsida Life Science Full time

    Cell Therapy Development ManagerWe are seeking a highly experienced professional to join our team as a Cell Therapy Development Manager. This is an exciting opportunity to shape R&D strategy and drive development in immunotherapy for solid tumors.About the JobThe successful candidate will lead a mission-driven team in designing and executing discovery and...


  • London, Greater London, United Kingdom Hobson Prior Full time

    At Hobson Prior, we are working alongside a leading biotech company to find an exceptional Cell Therapy Operations Manager. This role is focused on advancing cell and gene therapy.The salary for this position is approximately $80,000 - $110,000 per year, depending on location and experience.Job DescriptionCreate and implement strategies for cell therapy with...


  • London, Greater London, United Kingdom Pharma Search Full time

    Role DescriptionIn this unique opportunity, you will have the chance to join a leading Global Pharmaceutical Company as they undertake unprecedented investment and activity in Cell and Gene Therapy Research. As a Cell and Gene Therapy Program Director, you will play a key role in providing clear leadership to projects from concept to pre-clinical...


  • London, Greater London, United Kingdom Quell Tx Full time

    Job DescriptionWe are seeking a highly experienced Cell Therapy Production Manager to lead our manufacturing operations in the production of cell therapy products. As a key member of our team, you will be responsible for overseeing all aspects of Good Manufacturing Practice (GMP) production, ensuring adherence to timelines, budgets, and quality standards.The...