• Amylyx Pharmaceuticals (Cambridge, MA)
    …improvement of QC operations internally and at external CMOs/CTLs. Work with CMC Regulatory for authoring/coordinating and updating clinical and commercial ... apply. THE OPPORTUNITY The Quality team is expanding and looking to hire a Manager of QC/AD, reporting to the Director of QC/AD. This individual will be responsible… more
    Upward (07/04/25)
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  • Takeda Pharmaceutical Company Limited (Lexington, MA)
    …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). Minimum of 5 years' experience as a… more
    Upward (07/07/25)
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  • Senior Manager , Regulatory Affairs…

    AbbVie (Waltham, MA)
    …Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content… more
    AbbVie (07/25/25)
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  • Manager - CMC Dossier Strategy…

    AbbVie (Worcester, MA)
    …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Manager - CMC Dossier Strategy & Leadership participates in ... scientific and technical quality that are compliant with global regulatory requirements. They partner with CMC teams...with global regulatory requirements. They partner with CMC teams during the development of early-phase CMC more
    AbbVie (07/24/25)
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  • AI & Data Manager - Life Sciences R&D…

    Deloitte (Boston, MA)
    …(ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years ... equitable future of health. Work You'll Do As a Manager you will lead and deliver engagements, or components...+ 4+ years Life Sciences Chemistry, Manufacturing, and Controls ( CMC ) experience to include: + Introducing new technologies like… more
    Deloitte (07/17/25)
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  • Senior Manager , Global Regulatory

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
    Otsuka America Pharmaceutical Inc. (06/19/25)
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  • AI & Data Manager - Life Sciences R&D…

    Deloitte (Boston, MA)
    …health Recruiting for this role ends on 8/31/2025 Work You'll Do As a Manager you will lead and deliver engagements, or components of large, complex engagements. ... experience + 4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like GenAI, AI/ML, and… more
    Deloitte (07/09/25)
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  • Sr. Manager , Clinical Supply Chain

    BeOne Medicines (Cambridge, MA)
    …and provide a high service level to internal stakeholders (eg Clinical Operations, Regulatory , Quality, CMC ). + Work with Clinical Operations to understand ... BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Sr. Manager , Clinical Supply Chain in Cambridge, MA: **Job Duties:** + Represent the Clinical Supply Chain on Clinical… more
    BeOne Medicines (07/03/25)
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  • Associate Director, Clinical Research, Value…

    Takeda Pharmaceuticals (Lexington, MA)
    …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). + Minimum of 5 years' experience as… more
    Takeda Pharmaceuticals (05/03/25)
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  • PharmSci PM

    ManpowerGroup (Andover, MA)
    …organization for both early and late stage product development teams inclusive of CMC regulatory submission support. Early phase support will include the ... will directly impact patients. You will achieve A project manager role is available within the Biotherapeutics Portfolio &...and sub teams. . In both cases, the project manager will be responsible for assisting in the coordination… more
    ManpowerGroup (06/19/25)
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