Regulatory CMC Project Leader

7 days ago


London, Greater London, United Kingdom RBW Consulting Full time

We are seeking a skilled Regulatory CMC Project Manager to join our team at RBW Consulting.

The successful candidate will be responsible for overseeing regulatory activities for a small molecule oncology product globally.

This role involves working independently and with an outsourcing team on tasks such as change controls, out of specification assessments, PQRs, and clinical phase activities.

Key Responsibilities:

  • Implementing change control procedures
  • Managing out of specification assessments
  • Coordinating CMC commitments and variation submissions
  • Producing and Reviewing Product Quality Reviews (PQRs)
  • Collaborating with external Contract Manufacturing Organizations (CMOs)
  • Managing CMC regulatory activities for clinical programs, including:
  • Authoring Investigational New Drug (IND) and Investigational Medicinal Product Dossier (IMPD) documents
  • Responding to Health Authorities
  • Preparing documents for Qualified Person (QP) release
  • Post-submission management

Key Qualifications:

  • Over 10 years of experience in CMC technical roles, with at least 5 years in lifecycle management of small molecule products
  • Experience in pre- and post-approval CMC regulatory activities
  • Effective stakeholder management
  • Project management within a CMC context
  • Knowledge of IND/NDA and IMPD/MAA formats
  • Understanding of drug substance and product CMC
  • Organized, independent, and able to manage multiple activities
  • Degree in Pharmacy or a relevant science/technical subject
  • Language skills: Proficient in English, French is an advantage

This position will be a contract until the end of March 2025, with strong likelihood of extension for a further 6 month period.



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

    Regulatory CMC Project Manager OpportunityWe are seeking a highly experienced Regulatory CMC Project Manager to join our team at RBW Consulting. As a key member of our team, you will be responsible for overseeing regulatory activities for a small molecule oncology product globally.This is a contract position until the end of March 2025, with a strong...


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

    Job Description:At RBW Consulting, we are seeking a highly skilled Regulatory CMC Project Manager to join our team. The successful candidate will be responsible for overseeing regulatory activities for a small molecule oncology product globally.This is a contract position until the end of March 2025, with a strong likelihood of extension for a further 6...

  • Regulatory CMC Lead

    3 weeks ago


    London, Greater London, United Kingdom Vertex Full time

    Job Title: Regulatory CMC LeadJob Summary:Vertex is seeking a highly skilled Regulatory CMC Lead to influence the execution of multi-product global regulatory CMC strategies for investigational and marketed products. This role contributes to the preparation and submission of regulatory CMC documentation and interactions with Health Authorities for CMC...


  • London, Greater London, United Kingdom Vertex Full time

    Job Title: Regulatory CMC ManagerJob Summary:Vertex is seeking a highly skilled Regulatory CMC Manager to influence the execution of multi-product global regulatory CMC strategies for investigational and marketed products. This role contributes to the preparation and submission of regulatory CMC documentation and interactions with Health Authorities for CMC...


  • London, Greater London, United Kingdom Vertex Full time

    About the JobThe Regulatory Chemistry Manufacturing Controls (CMC) Manager will play a key role in Vertex's execution of multi-product global regulatory CMC strategies for investigational and marketed products.This role contributes to the preparation and submission of regulatory CMC documentation and interactions with Health Authorities for CMC topics....


  • London, Greater London, United Kingdom Vertex Full time

    Job Title: Regulatory CMC ManagerJob Summary:Vertex is seeking a highly skilled Regulatory CMC Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for influencing the execution of multi-product global regulatory CMC strategies for investigational and marketed products.Key Responsibilities:Review and analyze CMC...


  • London, Greater London, United Kingdom Vertex Full time

    Job Title: Regulatory CMC ManagerJob Summary:Vertex is seeking a highly skilled Regulatory CMC Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for influencing the execution of multi-product global regulatory CMC strategies for investigational and marketed products.Key Responsibilities:Review and analyze...


  • London, Greater London, United Kingdom Vertex Full time

    Job Title: Regulatory CMC ManagerJob Summary:Vertex is seeking a highly skilled Regulatory CMC Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for influencing the execution of multi-product global regulatory CMC strategies for investigational and marketed products.Key Responsibilities:Review and analyze...


  • London, Greater London, United Kingdom Vertex Full time

    Vertex Job Opening: Regulatory CMC ManagerJob Summary:The Regulatory Chemistry Manufacturing Controls (CMC) Manager will significantly contribute to the execution of global regulatory CMC strategies for investigational and marketed products at Vertex. This role will prepare and submit regulatory CMC documentation, interact with Health Authorities for CMC...


  • London, Greater London, United Kingdom Cpl Healthcare Full time

    Senior Regulatory CMC ConsultantCPL Life Sciences is collaborating with a global pharmaceutical business focused on the discovery, development, and commercialization of innovative medicines.As a Senior Regulatory CMC Consultant, you will be responsible for the development of CMC Strategy for a range of projects in the development phase, including the...


  • London, Greater London, United Kingdom Cpl Healthcare Full time

    Senior Regulatory CMC ConsultantRemote OpportunityCPL Life Sciences is collaborating with a global pharmaceutical company focused on the discovery, development, and commercialization of innovative medicines.As a Senior Regulatory CMC Consultant, you will be responsible for developing CMC strategies for various projects in the development phase, including...


  • London, Greater London, United Kingdom Cpl Healthcare Full time

    Role OverviewCPL Life Sciences is collaborating with a global pharmaceutical business focused on the discovery, development, and commercialization of innovative medicines.As a Senior Regulatory CMC Consultant, you will be responsible for the development of CMC Strategy for a range of projects in the development phase, including the preparation of CMC...


  • London, Greater London, United Kingdom CPL Healthcare Full time

    CPL Healthcare is seeking a highly skilled Senior Regulatory CMC Expert to join their team. As a key member of the CMC Strategy team, you will be responsible for developing and implementing CMC strategies for a range of projects in the development phase.Key Responsibilities:Define and implement CMC strategies for various projects in development.Prepare and...


  • London, Greater London, United Kingdom Cpl Healthcare Full time

    CPL Life Sciences is collaborating with a global pharmaceutical company focused on the discovery, development, and commercialization of innovative medicines.As a Senior Regulatory CMC Expert, you will be responsible for the development of CMC Strategy for a range of projects in the development phase, including the preparation of CMC submissions for...


  • London, Greater London, United Kingdom Parexel Full time

    Regulatory Affairs ConsultantParexel Consulting is seeking a seasoned CMC Regulatory Affairs Professional to collaborate with our team. As a Regulatory Affairs Consultant, you will utilize your expertise in CMC, excellent communication skills, and strong writing experience to contribute to our clients' success in the pharmaceutical industry.Key...


  • London, Greater London, United Kingdom Cpl Healthcare Full time

    CPL Life Sciences is collaborating with a global pharmaceutical business focused on the discovery, development, and commercialization of innovative medicines.As a Senior Regulatory CMC Expert, you will be responsible for developing CMC strategies for various projects in the development phase, including preparing CMC submissions for investigational products...


  • London, Greater London, United Kingdom Parexel Full time

    Job DescriptionParexel Consulting seeks a seasoned CMC Regulatory Affairs Professional as a Regulatory Affairs Consultant. This role offers the opportunity to utilize expertise in CMC, exceptional communication skills, and strong writing experience, contributing to clients' success in the pharmaceutical industry.Key Responsibilities:Assisting in technical...


  • London, Greater London, United Kingdom GSK Full time

    Job DescriptionOverviewGSK is seeking a highly skilled Director of Regulatory Affairs, CMC to lead key strategic CMC regulatory activities for investigational and/or early commercial biopharmaceuticals. As a key member of the Global Regulatory Affairs team, you will provide strategic direction and guidance on global project and key strategic business...


  • London, Greater London, United Kingdom GSK Full time

    Job DescriptionThe CMC Development Projects Regulatory Project Manager plays a pivotal role in the global regulatory activities for assigned projects, ensuring seamless execution and compliance with regulatory standards.Key Responsibilities:Develop and implement CMC regulatory strategies for global submissions, from early phase clinical trials to marketing...


  • London, Greater London, United Kingdom GSK Full time

    Job DescriptionAs a key strategic partner, you will represent Global Regulatory activities and provide strategic direction and guidance on global project and key strategic business initiatives. This role will lead key, strategic CMC regulatory activities for investigational and/or early commercial biological products.Key ResponsibilitiesLeads CMC regulatory...