• Genmab (Plainsboro, NJ)
    …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be ... portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to...Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be… more
    HireLifeScience (11/15/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …well as other research areas centered around rare diseases and immune disorders. Summary: The Associate Director , Regulatory Affairs - Regulatory ... provides planning and drives coordination of global and US regulatory activities. The Associate Director ...provides impactful contributions to the RPM group and the regulatory affairs organization by identifying gaps in… more
    HireLifeScience (01/06/25)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
    HireLifeScience (01/06/25)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …for a living. Are you ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and executing ... alignment with the Evidence Generation Plan (EGP). Externally, the Associate Director RP will be the lead...across CDSE and more broadly within Clinical, Medical and Regulatory , Market Access and Public Affairs . Externally,… more
    HireLifeScience (12/11/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …collaborators, as we embark on shaping our future. The Position The Associate Director , HCP Experience has overall strategic and operational responsibility ... to the Hemophilia Therapy Area Lead. Works closely with Associate Directors and Sr Brand Managers across the Rare...of the pharmaceutical industry including marketing, medical, access, public affairs , compliance, legal and regulatory as well… more
    HireLifeScience (12/07/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …or More Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
    HireLifeScience (12/19/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …planning and execution to assigned Novo Nordisk, Inc. therapeutic areas. Assist Associate Director with development and execution of annual strategic convention ... planning. Relationships Reports to the Manager, Convention Marketing reports to the Associate Director , Convention Marketing of the Strategic Meeting & Event… more
    HireLifeScience (11/23/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …other research areas centered around rare diseases and immune disorders.Summary: The Associate Director , Regional Marketing Conventions & Field Programs will be ... and more, while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field Programs is responsible… more
    HireLifeScience (01/01/25)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and… more
    HireLifeScience (12/13/24)
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  • Associate Director

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …well as other research areas centered around rare diseases and immune disorders. **Summary:** The Associate Director , Regulatory Affairs - Regulatory ... provides planning and drives coordination of global and US regulatory activities. The Associate Director ...provides impactful contributions to the RPM group and the regulatory affairs organization by identifying gaps in… more
    Daiichi Sankyo Inc. (01/07/25)
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  • Associate Director Regulatory

    Ascendis Pharma (Princeton, NJ)
    …and committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will ... trends governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and Promotion is… more
    Ascendis Pharma (12/10/24)
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  • Associate Director

    Taiho Oncology (Princeton, NJ)
    Associate Director , Regulatory Affairs Strategy Princeton, NJ, USA Req #415 Wednesday, November 27, 2024 Looking for a chance to make a meaningful ... filing in US and Europe. Position Summary: + Under the direction of regulatory affairs management, the incumbent independently prepares and directs global … more
    Taiho Oncology (11/28/24)
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  • Associate Director

    Sumitomo Pharma (Trenton, NJ)
    …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs ** . The ... Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as a Regional Regulatory Leader… more
    Sumitomo Pharma (11/21/24)
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  • Associate Director , Global…

    Takeda Pharmaceuticals (Trenton, NJ)
    …employment application is true to the best of my knowledge. **Job Description** The Regulatory Affairs -Labeling, Associate Director is responsible for ... to the world. **How you will contribute:** + The Associate Director , GRA Labeling Compliance, is responsible...global and local labeling compliance and quality within Global Regulatory Affairs . + Partners with internal stakeholders… more
    Takeda Pharmaceuticals (11/27/24)
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  • Associate Director

    Bristol Myers Squibb (Princeton, NJ)
    …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
    Bristol Myers Squibb (01/07/25)
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  • Associate Director , US…

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
    Daiichi Sankyo Inc. (12/18/24)
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  • Associate Director , Global…

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
    Daiichi Sankyo Inc. (10/19/24)
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  • Associate Director , Field Medical…

    Sumitomo Pharma (Trenton, NJ)
    …. **Job Overview** Associate Director , Field Medical and Scientific Affairs ... summarizes, and disseminates key insights obtained from the RDs to the Medical Affairs and other internal stakeholders in a timely manner. + Participate in the… more
    Sumitomo Pharma (12/14/24)
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  • Regulatory Affairs Clinical FDA…

    Amneal Pharmaceuticals (Piscataway, NJ)
    …The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical/ FDA Communications.Assists the Senior ... Director of Regulatory Affairs / Clinical Affairs in managing, coordinating, tracking and follow-up on FDA Communications and ANDA status for assigned… more
    Amneal Pharmaceuticals (11/14/24)
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  • Associate Director , Global…

    Takeda Pharmaceuticals (Trenton, NJ)
    …company that will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning - GI2 ... TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs)… more
    Takeda Pharmaceuticals (10/24/24)
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