• Executive Medical Director - Cardio-Renal

    Lilly (Boston, MA)
    …therapeutic indications as determined by Cardio-Renal and DOCTA management. The Executive Director will also supervise the implementation of global clinical ... patient safety; the review process for protocols, study reports, publications, regulatory submissions and data dissemination. The Executive Director will… more
    Lilly (09/06/25)
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  • Associate Director , Inspection Readiness

    Bristol Myers Squibb (Devens, MA)
    …approach. **Key Responsibilities** * Monitor and assess global regulatory inspection outcomes, enforcement actions, quality and compliance metrics, ... strategies by providing expert guidance on the interpretation and application of global regulatory requirements, as required. * Develop and maintain strong… more
    Bristol Myers Squibb (09/24/25)
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  • GRA Device Lead (Associate Director )

    Sanofi Group (Framingham, MA)
    …families. Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team ... department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing… more
    Sanofi Group (09/23/25)
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  • GRA Device Lead (Associate Director )

    Sanofi Group (Cambridge, MA)
    …families. Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team ... department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing… more
    Sanofi Group (09/20/25)
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  • GRA Device Lead ( Director )

    Sanofi Group (Cambridge, MA)
    …diagnostic products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within ... **Job Title:** GRA Device Lead ( Director ) **Location** : Morristown, NJ, Cambridge, MA, Framingham,...Global Research and Development. Sanofi's global regulatory affairs (GRA) function is comprised… more
    Sanofi Group (07/15/25)
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  • Director , Commercial Drug Products & Life…

    Amgen (Cambridge, MA)
    …and implement strategy for commercial drug product programs, life-cycle management, global regulatory submissions, and variation management for biologics, ... key messages relative to diverse audience requirements + Knowledge of applicable global regulatory requirements. Experience preparing technical sections of … more
    Amgen (09/26/25)
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  • Senior Director , Radioligand Therapy…

    Sanofi Group (Cambridge, MA)
    …timely, and seamless delivery of this time-sensitive therapy, we are seeking a **US/ Global Director , Radioligand Therapy (RLT) Delivery & Customer Services** . ... **Job Title:** Senior Director , Radioligand Therapy Delivery and Customer Service **Location:**...governance forums to align priorities and resolve operational challenges. ** Regulatory & Quality Compliance** + Ensure all… more
    Sanofi Group (09/19/25)
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  • Director , Internal Audit

    Hologic (Marlborough, MA)
    …ISO standards (eg, ISO 13485:2016, ISO 14971), MDSAP, and other global regulatory requirements. + Expertise in Quality Systems and GMP compliance in ... a pivotal role in ensuring the effectiveness of our global Quality Systems. In this critical leadership...ensuring compliance with FDA regulations, ISO standards, and other global regulatory requirements. If you thrive in… more
    Hologic (09/16/25)
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  • Director , Labeling Council and Regional…

    Takeda Pharmaceuticals (Boston, MA)
    …to bring life-changing therapies to patients worldwide. As a key leader within Global Labeling Operations, the Director , Labeling Council and Regional Labeling, ... ways of working. + Partner with key stakeholders, including Global Labeling, EUCAN Regulatory Liaison and GEM...years experience in pharmaceutical industry, with 4 years in Regulatory Affairs, labeling or quality assurance/compliance. +… more
    Takeda Pharmaceuticals (09/25/25)
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  • Director , Patient Services and HUB

    Sumitomo Pharma (Boston, MA)
    …services execution and fosters strategic partnerships with service providers to deliver high- quality patient support. The Director plays a critical role in ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...Quality :** + Ensure all programs adhere to relevant regulatory and legal standards, including HIPAA. **Qualifications & Skills:**… more
    Sumitomo Pharma (08/15/25)
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