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    Chemistry Manufacturing Controls Manager - London, United Kingdom - Vertex Pharmaceuticals

    Vertex Pharmaceuticals
    Vertex Pharmaceuticals London, United Kingdom

    4 days ago

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    Description

    Chemistry Manufacturing Controls Manager - 12-month FTC page is loaded

    Chemistry Manufacturing Controls Manager - 12-month FTC

    Apply locations Paddington, United Kingdom time type Full time posted on Posted 2 Days Ago job requisition id REQ-21134

    Job Description

    General Summary:

    The Chemistry Manufacturing Controls Manager will influence the execution of multi-product global regulatory CMC strategies for marketed products. This role contributes to the preparation and submission of regulatory CMC documentation and with interactions with Health Authorities for CMC topics. This role also provides regulatory support and guidance to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into commercial programs.

    Key Duties and Responsibilities:

    • Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
    • Contributes to the development of global regulatory CMC strategies for commercial products
    • Works with regulatory colleagues in development of global regulatory CMC strategies and submissions
    • Provides regulatory CMC guidance to cross-functional teams and key stakeholders
    • Influences regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
    • Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects

    Knowledge and Skills:

    • Strong interpersonal skills to exchange complex information with others and to guide others
    • Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines
    • Experience in the preparation, including writing, of CMC submissions
    • Strategic thinking and strong problem solving skills
    • Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
    • Strong sense of planning and prioritization, and the ability to work with all levels of management
    • Capable of strategic thinking with ability to resolve complex and ambiguous situationsSound knowledge of cGMP, FDA, EMA, ICH

    Education and Experience:

    • Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field
    • Extensive experience in the pharmaceutical industry or related field, or the
      equivalent combination of education and experience
    • Requires a high level of experience in CMC regulatory post approval variations

    Company Information

    Vertex is a global biotechnology company that invests in scientific innovation.

    Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

    Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at

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    Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency .

    Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on Facebook , Twitter/X , LinkedIn , YouTube and Instagram .

    The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives.

    Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.

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