• Legal: IP Legal Counsel

    Nanobiosym, Inc. (Cambridge, MA)
    …IP-related matters, including licensing agreements, collaborations, M&A due diligence, and regulatory submissions . + Dispute Resolution: Support IP litigation, ... strategies. + Prior in-house legal experience in a biotech or pharmaceutical company. + Familiarity with regulatory frameworks (eg, FDA, EMA) as they relate to IP. more
    Nanobiosym, Inc. (07/24/25)
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  • Supplier Project Manager - Electrical

    J&J Family of Companies (Danvers, MA)
    …and constructively challenging the status quo + Basic understanding of medical device regulatory submissions + Dedicated, passionate and eager to learn + Sound ... develop supply chain phase-in plans accounting for various medical device regulatory approval timelines + Qualify and implement dimensional and visual inspections… more
    J&J Family of Companies (07/23/25)
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  • Research Investigator Analytical Development

    Takeda Pharmaceuticals (Boston, MA)
    …performance that enable optimization of drug products, and potentially aid in regulatory submissions . Full time. $108,600.00 - $165,600.00 per year. Competitive ... technical or process related work streams; author technical reports and contributes to regulatory filings. Up to 10% domestic travel required; Up to 20% remote work… more
    Takeda Pharmaceuticals (07/12/25)
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  • Director, Computational & Systems Biology - Early…

    Takeda Pharmaceuticals (Boston, MA)
    …Multi-omics and genetics discovery and development as demonstrated by publications, regulatory submissions and/or national or international presentations + ... Excellent understanding of drug development, regulatory processes, and clinical development + Strong leadership abilities and proven ability to lead a team within a… more
    Takeda Pharmaceuticals (07/04/25)
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  • Research Data Specialist - GYN Oncology

    Dana-Farber Cancer Institute (Boston, MA)
    …tracking systems (STIP) and laboratory binders. + May be responsible for IRB and regulatory submissions and maintenance of regulatory files. + Bachelor's ... Degree required. + Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred. **KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:** + Excellent organizational and communication skills required. +… more
    Dana-Farber Cancer Institute (06/24/25)
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  • Senior Research Investigator/Associate Director,…

    Bristol Myers Squibb (Cambridge, MA)
    …evaluating competitive differentiation, and supporting internal decision-making and regulatory submissions . Experience in virtual population development ... mechanistic models to support clinical study design, dose selection, and regulatory strategy * Engage external collaborators to accelerate modeling efforts in… more
    Bristol Myers Squibb (06/06/25)
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  • Scientific Writer (Onsite Consultant)

    Nanobiosym, Inc. (Cambridge, MA)
    …organizational objectives. + Translate technical research into accessible content for regulatory submissions , funding bodies, and public communication. + Review ... writing for both technical and non-technical audiences. + Familiarity with grant and funding proposal writing. + Knowledge of regulatory or policy writing is a plus. more
    Nanobiosym, Inc. (05/19/25)
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  • Director, Clinical Biomarker, Late Stage Neurology…

    Bristol Myers Squibb (Cambridge, MA)
    …+ Participates in post-hoc biomarker analysis and publication efforts + Supports regulatory submissions and regulatory interactions as needed ... **Skills/Knowledge Required** + 7+ years of late stage clinical biomarker experience in industry (biotech/pharma) + Recognized expertise in translational biomarkers in neurology space + Experience in late stage drug development and activities required for and… more
    Bristol Myers Squibb (05/07/25)
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  • Program Manager, Regulatory Affairs…

    Olympus Corporation of the Americas (Westborough, MA)
    …device submissions for Canadian Class 2, 3 or 4 Device License submissions . + Lead development of responses to regulatory authorities' requests for ... years with BS/BA, or 7 years with MS preferred. + Regulatory affairs experience in writing US submissions and EU submissions is mandatory and experience in… more
    Olympus Corporation of the Americas (06/18/25)
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  • Associate Director, Product Quality

    AbbVie (Waltham, MA)
    …of monographs of the Ph. Eur. Documents. Lead QA contact with AbbVie Affiliates and Regulatory to prepare submissions and partic + Makes key decisions on product ... corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and… more
    AbbVie (07/11/25)
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