• Associate Director , Regulatory

    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 difference ... 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)
    - Save Job - Related Jobs - Block Source
  • Associate Director Regulatory

    Ascendis Pharma (Princeton, NJ)
    …committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be an ... promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and..., Advertising and Promotion is responsible for providing commercial regulatory strategy and leadership to enable the US more
    Ascendis Pharma (12/10/24)
    - Save Job - Related Jobs - Block Source
  • Associate Director , Regulatory

    Sumitomo Pharma (Trenton, NJ)
    …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 ....I-IV Research & Development Activities** + As a Regional Regulatory Lead, manage regional ( United States more
    Sumitomo Pharma (11/21/24)
    - Save Job - Related Jobs - Block Source
  • Director , Regulatory Affairs

    Sumitomo Pharma (Trenton, NJ)
    …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US ....I-IV Research & Development Activities + As a Regional Regulatory Lead, manage regional ( United States more
    Sumitomo Pharma (11/28/24)
    - Save Job - Related Jobs - Block Source
  • Director , Regulatory Affairs

    Regeneron Pharmaceuticals (Basking Ridge, NJ)
    The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on...you if:** + If you bring strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development… more
    Regeneron Pharmaceuticals (12/11/24)
    - Save Job - Related Jobs - Block Source
  • Director , Legislative & Regulatory

    NJEDA (Trenton, NJ)
    …New Jersey's future with innovative economic development at NJEDA. Job Overview + The Director of Legislative and Regulatory Affairs works to support the ... The Director will report to the Managing Director of Legislative and Regulatory Affairs...Selected candidates must be authorized to work in the United States per the Department of Homeland… more
    NJEDA (12/24/24)
    - Save Job - Related Jobs - Block Source
  • Associate Director , Global…

    Takeda Pharmaceuticals (Trenton, NJ)
    …application is true to the best of my knowledge. **Job Description** The Regulatory Affairs -Labeling, Associate Director is responsible for ensuring that ... pertaining to global and local labeling compliance and quality within Global Regulatory Affairs . + Partners with internal stakeholders and external CRO… more
    Takeda Pharmaceuticals (11/27/24)
    - Save Job - Related Jobs - Block Source
  • Senior Director , US

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …leader will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA ... accountable for ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US more
    Daiichi Sankyo Inc. (11/13/24)
    - Save Job - Related Jobs - Block Source
  • Director , US Regulatory

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... growth, thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan… more
    Daiichi Sankyo Inc. (12/01/24)
    - Save Job - Related Jobs - Block Source
  • Associate Director , US

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and… more
    Daiichi Sankyo Inc. (12/18/24)
    - Save Job - Related Jobs - Block Source
  • Director , US Regulatory

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …+ 7 or More Years in the pharmaceutical industry + 4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA **Travel** Ability to travel up to ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
    Daiichi Sankyo Inc. (11/09/24)
    - Save Job - Related Jobs - Block Source
  • Director Global Regulatory

    Takeda Pharmaceuticals (Trenton, NJ)
    …of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and… more
    Takeda Pharmaceuticals (12/06/24)
    - Save Job - Related Jobs - Block Source
  • Director Global Regulatory

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA submission experience + ... and immune disorders. **Summary:** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
    Daiichi Sankyo Inc. (12/18/24)
    - Save Job - Related Jobs - Block Source
  • Associate Director , Global…

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …More Years pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + ... US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI,… more
    Daiichi Sankyo Inc. (10/19/24)
    - Save Job - Related Jobs - Block Source
  • Regulatory Affairs Clinical FDA…

    Amneal Pharmaceuticals (Piscataway, NJ)
    Description: 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...Audits conducted by the CRA ANDA Department within the US and International. + Submission/tracking of inter department communications… more
    Amneal Pharmaceuticals (11/14/24)
    - Save Job - Related Jobs - Block Source
  • Director , Medical Affairs Strategy…

    Sumitomo Pharma (Trenton, NJ)
    us .sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The Director , Medical Affairs Strategy (Hematology/Oncology) will be a key member of ... company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada,...the Medical Affairs team reporting to the Executive Director ,… more
    Sumitomo Pharma (11/27/24)
    - Save Job - Related Jobs - Block Source
  • Senior Director , Medical Affairs

    Sumitomo Pharma (Trenton, NJ)
    Director , Medical Strategy (Rare Disease) will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada,...and external facing HCP and Payer interactions. The Sr. Director of Medical Affairs develops and maintains… more
    Sumitomo Pharma (11/21/24)
    - Save Job - Related Jobs - Block Source
  • Director , Medical Affairs Strategy…

    Sumitomo Pharma (Trenton, NJ)
    …. **Job Overview** The ** Director , Medical Strategy (Prostate Cancer)** ... company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada,...will be a key member of the Medical Affairs team reporting to the Executive Director ,… more
    Sumitomo Pharma (12/05/24)
    - Save Job - Related Jobs - Block Source
  • Sr. Medical Director , Medical…

    Taiho Oncology (Princeton, NJ)
    …such as: Clinical Development, Commercial, Evidence and Value Development, Market Access and Regulatory Affairs to ensure, as needed, alignment and inputs + ... Sr. Medical Director , Medical Affairs Princeton, NJ, USA...organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more… more
    Taiho Oncology (11/27/24)
    - Save Job - Related Jobs - Block Source
  • Associate Director , Field Medical…

    Sumitomo Pharma (Trenton, NJ)
    …. **Job Overview** Associate Director , Field Medical and Scientific ... company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada,...key insights obtained from the RDs to the Medical Affairs and other internal stakeholders in a timely manner.… more
    Sumitomo Pharma (12/14/24)
    - Save Job - Related Jobs - Block Source