Regulatory CMC Manager

2 days ago

London, Greater London, United Kingdom Vertex Full time

Job 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 play a critical role in influencing the execution of multi-product global regulatory CMC strategies for investigational and marketed products.

Key Responsibilities:

  • Review and analyze CMC sections of regulatory submissions, as well as interactions and responses with regulatory agencies to ensure compliance with global regulatory requirements.
  • Contribute to the development of global regulatory CMC strategies for investigational and/or commercial products, working closely with cross-functional teams to ensure alignment with business objectives.
  • Provide regulatory CMC guidance and support to cross-functional teams, including development, manufacturing, and quality assurance, to ensure compliance with global regulatory requirements.
  • Influence regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations, to ensure timely and effective resolution of issues.
  • Participate effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects, providing strategic guidance and support to ensure successful project outcomes.

Requirements:

  • Strong understanding of regulatory guidelines and requirements, including FDA, EMA, Health Canada, and ICH.
  • Experience in the preparation, including writing, of CMC submissions, with a strong focus on quality and accuracy.
  • Strategic thinking and strong problem-solving skills, with the ability to analyze complex data and develop effective solutions.
  • Excellent communication and interpersonal skills, with the ability to exchange complex information with others and guide others.
  • Strong sense of planning and prioritization, with the ability to work with all levels of management to ensure timely and effective project outcomes.

Education:

  • Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field.

  • Regulatory CMC Strategy Manager

    5 days ago

    London, Greater London, United Kingdom Pfizer Full time

    Job DescriptionPfizer is seeking a highly skilled Regulatory CMC Strategy Manager to join our team. As a key member of our global regulatory affairs team, you will play a critical role in ensuring the successful development and approval of our pharmaceutical products.Key Responsibilities:Collaborate with cross-functional teams to progress Pfizer's business...

  • Regulatory CMC Strategy Manager

    5 days ago

    London, Greater London, United Kingdom Pfizer Full time

    Job DescriptionPfizer is seeking a highly skilled Regulatory CMC Strategy Manager to join our team. As a key member of our global regulatory affairs team, you will play a critical role in ensuring the successful development and approval of our pharmaceutical products.Key Responsibilities:Collaborate with cross-functional teams to progress Pfizer's business...

  • CMC Regulatory Affairs Leader

    1 week ago

    London, Greater London, United Kingdom wax. Full time

    Unlock Your Potential in CMC Regulatory AffairsWe are seeking a seasoned expert in Chemistry, Manufacturing, and Controls (CMC) to lead our regulatory affairs team. As a dynamic leader, you will steer multi-modality projects from development to commercialisation, ensuring high-quality regulatory submissions.Key Responsibilities:Lead the preparation and...

  • Senior Regulatory CMC Consultant

    1 week ago

    London, Greater London, United Kingdom Cpl Healthcare Full time

    Job SummaryCPL 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 the development of CMC Strategy for a range of projects in the development phase, including the preparation of CMC...

  • Senior Regulatory CMC Consultant

    6 days ago

    London, Greater London, United Kingdom Cpl Healthcare Full time

    Job SummaryCPL 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 the development of CMC Strategy for a range of projects in the development phase, including the preparation of CMC...

  • CMC Lead, Regulatory Affiars

    2 months ago

    London, Greater London, United Kingdom Hobson Prior Full time

    Hobson Prior is seeking a CMC Lead for Regulatory Affairs. This role will focus on leading a team in the field of gene therapy, reporting to the Vice President of Regulatory Affairs. The successful candidate will be responsible for developing and implementing regulatory strategies across all gene therapy projects, identifying and managing regulatory risks,...

  • Risk Management Specialist

    5 days ago

    London, Greater London, United Kingdom CMC Markets Full time

    Job SummaryCMC Markets is seeking a highly skilled Risk Management Specialist to join our team. As a Risk Management Specialist, you will play a critical role in ensuring the company's third-party risk management framework is robust and effective.Key ResponsibilitiesConduct thorough assessments of potential and existing third-party vendors to identify and...

  • Risk Management Specialist

    5 days ago

    London, Greater London, United Kingdom CMC Markets Full time

    Job SummaryCMC Markets is seeking a highly skilled Risk Management Specialist to join our team. As a Risk Management Specialist, you will play a critical role in ensuring the company's third-party risk management framework is robust and effective.Key ResponsibilitiesConduct thorough assessments of potential and existing third-party vendors to identify and...

  • Regulatory Risk Professional

    3 days ago

    London, Greater London, United Kingdom CMC Markets Full time

    We are seeking a talented Regulatory Risk Graduate to join our team at CMC Markets, a leading global fintech company.This is a fantastic opportunity to gain exposure across a fast-paced, high-growth business landscape and work on critical functions that are essential to the success of any medium-to-large sized financial services firm.Key...

  • Regulatory Risk Professional

    3 days ago

    London, Greater London, United Kingdom CMC Markets Full time

    We are seeking a talented Regulatory Risk Graduate to join our team at CMC Markets, a leading global fintech company.This is a fantastic opportunity to gain exposure across a fast-paced, high-growth business landscape and work on critical functions that are essential to the success of any medium-to-large sized financial services firm.Key...

  • Regulatory Risk Graduate Programme

    3 weeks ago

    London, Greater London, United Kingdom CMC Markets Full time

    Are you passionate about finance and eager to build a rewarding career in a dynamic global environment? CMC Markets is seeking highly motivated graduates to join our prestigious Regulatory Risk Graduate Programme. This comprehensive programme offers an unparalleled opportunity to gain invaluable experience across key control functions within a leading...

  • Head of Global CMC Compliance

    18 hours ago

    London, Greater London, United Kingdom Fraser Dove International Full time

    Job Title: Head of Global CMC ComplianceFraser Dove International is partnering with a leading pharmaceutical organization to find a strategic leader to oversee Global CMC Compliance.About the Role:The Head of Global CMC Compliance will be responsible for ensuring regulatory compliance of all medicinal products and medical devices with applicable guidelines,...

  • Head of Global CMC Compliance

    20 hours ago

    London, Greater London, United Kingdom Fraser Dove International Full time

    Job Title: Head of Global CMC ComplianceFraser Dove International is partnering with a leading pharmaceutical organization to find a strategic leader to oversee Global CMC Compliance.About the Role:The Head of Global CMC Compliance will be responsible for ensuring regulatory compliance of all medicinal products and medical devices with applicable guidelines,...

  • Head of Global CMC Compliance

    4 days ago

    London, Greater London, United Kingdom Fraser Dove International Full time

    About the RoleWe are seeking a highly experienced and skilled professional to lead our Global CMC Compliance function. As the Head of Global CMC Compliance, you will be responsible for ensuring regulatory compliance of all medicinal products and medical devices with applicable guidelines, regulations, and approved authorizations.Key ResponsibilitiesDevelop...

  • Head of Global CMC Compliance

    4 days ago

    London, Greater London, United Kingdom Fraser Dove International Full time

    About the RoleWe are seeking a highly experienced and skilled professional to lead our Global CMC Compliance function. As the Head of Global CMC Compliance, you will be responsible for ensuring regulatory compliance of all medicinal products and medical devices with applicable guidelines, regulations, and approved authorizations.Key ResponsibilitiesDevelop...

  • Senior Client Asset Manager

    6 days ago

    London, Greater London, United Kingdom CMC Markets Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Client Asset Manager to join our Client Asset Management Team within the Finance Department at CMC Markets. As a key member of our team, you will play a critical role in ensuring the firm's compliance with its obligations under the Financial Conduct Authority (FCA), CASS, and similar...

  • Senior Client Asset Manager

    6 days ago

    London, Greater London, United Kingdom CMC Markets Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Client Asset Manager to join our Client Asset Management Team within the Finance Department at CMC Markets. As a key member of our team, you will play a critical role in ensuring the firm's compliance with its obligations under the Financial Conduct Authority (FCA), CASS, and similar...

  • Global CMC Compliance Leader

    4 days ago

    London, Greater London, United Kingdom Fraser Dove International Full time

    Job DescriptionJob Title: Global CMC Compliance LeaderJob Summary:Fraser Dove International is seeking a highly skilled and experienced Global CMC Compliance Leader to join our client, a leading pharmaceutical organization. As a key member of the global quality team, you will be responsible for ensuring regulatory compliance of all medicinal products and...

  • Global CMC Compliance Leader

    2 days ago

    London, Greater London, United Kingdom Fraser Dove International Full time

    Job DescriptionJob Title: Global CMC Compliance LeaderCompany: Fraser Dove InternationalJob Type: Full-timeLocation: RemoteJob Category: ComplianceAbout Us: Fraser Dove International is a leading executive search firm specializing in the life sciences industry. We help exceptional organizations source top talent to drive innovation and growth.About the...

  • Global CMC Compliance Leader

    2 days ago

    London, Greater London, United Kingdom Fraser Dove International Full time

    Job DescriptionJob Title: Global CMC Compliance LeaderCompany: Fraser Dove InternationalJob Type: Full-timeLocation: RemoteJob Category: ComplianceAbout Us: Fraser Dove International is a leading executive search firm specializing in the life sciences industry. We help exceptional organizations source top talent to drive innovation and growth.About the...