• Senior Manager , CMC Global…

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    Provide CMC regulatory strategy input and expertise...and inquiries. + Represents CMC RA in project team meetings and provides regulatory guidance ... technology, drug manufacturing processes, GMP and related issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development… more
    Otsuka America Pharmaceutical Inc. (04/25/25)
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  • Scientist I, Chemistry, Manufacturing & Control…

    Cardinal Health (Boston, MA)
    …systems and contributes to reports and presentations for clients. May serve as a project manager for smaller projects and ensure that team members achieve ... hands-on guidance of experienced Scientists, learns variety of internal, client, and regulatory systems and develop authoring and project management skills… more
    Cardinal Health (05/02/25)
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  • Regulatory & Quality Compliance…

    Fresenius Medical Center (Waltham, MA)
    …to comply with regulatory requirements + Organization of submission-readiness of regulatory documentation (eg, CMC relevant parts) + Organize and support ... The internal Job Title is called **Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).** **Main Responsibilities:** + Support as … more
    Fresenius Medical Center (04/01/25)
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  • Senior Manager , Global Regulatory…

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… more
    Otsuka America Pharmaceutical Inc. (04/23/25)
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  • Senior Manager , CTA Regulatory…

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    The Sr. Manager , CTA Regulatory Strategy is responsible for providing critical support in developing global regulatory strategy, planning, and execution of ... budgets + Work collaboratively with members of the global regulatory team (GRL, Clinical Transparency, Medical Writing, GRA- CMC...to regulatory agencies and compliance with electronic regulatory standards + Oversees project team members… more
    Otsuka America Pharmaceutical Inc. (04/17/25)
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  • Global Project Manager

    Sanofi Group (Cambridge, MA)
    **Job Title:** Global Project Manager **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to shape the future of medicine? The race is on ... Project & Planning Management as a Global Project Manager and you'll act as a...a deep knowledge of the contributions across all functions ( CMC , clinical, regulatory , medical affairs, market access,… more
    Sanofi Group (05/06/25)
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  • In Silico First Program and Strategy…

    Takeda Pharmaceuticals (Boston, MA)
    …integral part of the Pharmaceutical Sciences Sustainability and Technology (PSST) Sustainable CMC & Innovation team within PharmSci, In Silico First Program and ... Strategy Manager is crucial to operational efficiency & technical direction...and driving new operational methodologies, while adhering to evolving regulatory compliance requirements. Moreover, this role establishes key metrics… more
    Takeda Pharmaceuticals (04/16/25)
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  • Associate Director, Clinical Research, Value…

    Takeda Pharmaceuticals (Lexington, MA)
    …progress; manage individual study budgets and communicates status to appropriate TA project manager ; and execute communication and change management plans. + ... in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical… more
    Takeda Pharmaceuticals (05/03/25)
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  • Executive Director, Global Program Leader (GPL)

    Takeda Pharmaceuticals (Boston, MA)
    …role is defined by Takedas' values of Patient-Trust-Reputation-Business. In addition to project specific responsibilities, the ED GPL may be called upon to represent ... strong enterprise leaders + be committed to simultaneously driving regulatory approval as well as product launch and global...through the functional sub-teams leaders and their teams all project deliverables achieve defined project scope &… more
    Takeda Pharmaceuticals (04/12/25)
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  • Senior Director, Global Program Leader (GPL)

    Takeda Pharmaceuticals (Boston, MA)
    …experienced, versatile and strong enterprise leaders + Committed to simultaneously driving regulatory approval as well as launch and global patient access + Ability ... The GPL ensures through the functional sub-teams leaders and their teams all project deliverables achieve defined project scope & objectives, budget and… more
    Takeda Pharmaceuticals (02/15/25)
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