• Senior Clinical Outcomes Assessment (COA) Lead

    Sanofi Group (Morristown, NJ)
    …strategy implementation + Knowledge of the drug development process and the regulatory ( FDA , EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, other ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research… more
    Sanofi Group (07/15/25)
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  • R&D Microbiology Manager- Foods

    Unilever (Englewood Cliffs, NJ)
    …- Representing and guiding Unilever as the face of Microbiology to external regulatory bodies ( FDA , CFIA, etc.) + Micro validation support (formulation advice ... and process validations, strong factory hygienic design and sanitation experience, and FDA FSMA Preventative Controls. + Must have proven, relevant past experience… more
    Unilever (07/19/25)
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  • Scientific Director/Senior Scientific Director,…

    Bristol Myers Squibb (Princeton, NJ)
    …that advance R&D Project Team objectives and encompass drug substance, drug product, analytical, quality, regulatory , and clinical supplies. + Represents the ... innovative solutions to complex CMC technical challenges. + Strong knowledge of global regulatory guidelines and requirements (eg, FDA , EMA, ICH guidelines). +… more
    Bristol Myers Squibb (08/21/25)
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  • GRA CMC Lead, Vaccines

    Sanofi Group (Morristown, NJ)
    …ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could ... possible. Ready to get started? **Main Responsibilities:** + Develop CMC regulatory strategies and assess associated risks for development projects and/or registered… more
    Sanofi Group (07/02/25)
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  • Program Safety Lead, GPS Medical Science

    Ascendis Pharma (Princeton, NJ)
    …our core values of Patients, Science, and Passion, we use our TransCon(R) drug development platform to fulfill our mission of developing new and potentially ... direction of Head of GPS Medical Science, is responsible for all assigned Ascendis Drug Safety PV related activities for all products in the Ascendis portfolio. This… more
    Ascendis Pharma (07/17/25)
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  • Senior Counsel, R&D Innovation Legal (Specialty,…

    AbbVie (Florham Park, NJ)
    …R&D organization in navigating enterprise-critical issues in an evolving legal and regulatory environment as we work to bring new, innovative products to patients. ... leaders within the R&D and corporate strategy organizations on legal and regulatory issues that impact pipeline development, government agency engagement and product… more
    AbbVie (06/02/25)
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  • Associate Director, GVP Audits

    Gilead Sciences, Inc. (Parsippany, NJ)
    …knowledge of the drug development process and GVP, including global regulations ( FDA , EMA, ICH) and their application to cross-functional drug development. + ... regarding audit outcomes and CAPAs. Beyond auditing, this role supports regulatory inspections, readiness, and partners with the R&D Quality Extended Leadership… more
    Gilead Sciences, Inc. (08/08/25)
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  • Director, GCP Audits

    Gilead Sciences, Inc. (Parsippany, NJ)
    …the drug development process and GCP, including global regulations ( FDA , EMA, ICH) and their application to cross-functional clinical development. + Proficient ... improvements in R&D quality processes, systems, and standards to meet regulatory requirements and organizational goals and contribute to the overall quality… more
    Gilead Sciences, Inc. (08/21/25)
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  • Senior Quality Engineer I - Validations, Risk…

    Integra LifeSciences (Plainsboro, NJ)
    …a thorough understanding of the following regulations and guidelines: US Food and Drug Administration ( FDA ) regulations, ISO 9001, ISO 13485:2003, Medical Device ... Regulations (CMDR), Integra Corporation's policies and procedures, and other applicable regulatory agency requirements. + Participate in FDA inspections, ISO… more
    Integra LifeSciences (07/09/25)
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  • The Head of EGDS Innovation and Center…

    Sanofi Group (Morristown, NJ)
    …and various R&D functions such as patient safety/pharmocovigilance, patient focused drug development, portfolio management, global regulatory and digital ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...biomarkers.Cultivaterepresentation of Sanofi at key industry conferences (eg DIA, FDA industry workshop) and academic forums. + Establish and… more
    Sanofi Group (06/05/25)
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