• Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology… more
    HireLifeScience (04/21/24)
    - Save Job - Related Jobs - Block Source
  • Novo Nordisk Inc. (Plainsboro, NJ)
    …this role, the incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the ... Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing… more
    HireLifeScience (06/04/24)
    - Save Job - Related Jobs - Block Source
  • Merck & Co. (North Wales, PA)
    …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... & Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug Development… more
    HireLifeScience (06/26/24)
    - Save Job - Related Jobs - Block Source
  • Genmab (Princeton, NJ)
    …determined to be our best, and authentic is essential to fulfilling our purpose. Senior Director , Global Program Leader Genmab is seeking an experienced Global ... team with working knowledge across multiple R&D functions (preclinical, clinical, regulatory , CMC ) Clinical development experience required; late-stage clinical… more
    JobGet (07/01/24)
    - Save Job - Related Jobs - Block Source
  • Senior Director , CMC

    Gilead Sciences, Inc. (Foster City, CA)
    …35 countries worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is ... product in Gilead's global portfolio of biological products in CMC Regulatory Affairs. This position will provide...by maintaining the global licensures. In addition, the Sr Director will be accountable for leading the interpretation and… more
    Gilead Sciences, Inc. (07/02/24)
    - Save Job - Related Jobs - Block Source
  • Senior Director Regulatory

    Teva Pharmaceuticals (West Chester, PA)
    Senior Director Regulatory Affairs CMC (Biologic Products) Date: Jun 13, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... and new people to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible to oversee and help develop … more
    Teva Pharmaceuticals (05/16/24)
    - Save Job - Related Jobs - Block Source
  • Director , CMC Industry…

    Regeneron Pharmaceuticals (Troy, NY)
    The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance ... all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory...of related experience regulated industry or health authority + Senior Director : 20+ years of related experience… more
    Regeneron Pharmaceuticals (06/13/24)
    - Save Job - Related Jobs - Block Source
  • Senior Director , GRA - CMC

    Takeda Pharmaceuticals (Boston, MA)
    …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule where you ... trade associations and acts as an advisor/ liaison to senior management to plan, evaluate and recommend implementation strategy....CMC team, you will report to the Executive Director and Head, CMC Regulatory more
    Takeda Pharmaceuticals (06/12/24)
    - Save Job - Related Jobs - Block Source
  • CMC Statistician, Associate Director

    Sanofi Group (Framingham, MA)
    …to process development activities. + Broad knowledge of (bio)pharmaceutical development and CMC activities in a regulatory context, including good understanding ... discovery and development to find answers for patients and their families. The CMC -Biologics Statistics team is seeking an expert data scientist / Statistician to… more
    Sanofi Group (06/09/24)
    - Save Job - Related Jobs - Block Source
  • Associate Director , CMC Lead

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology… more
    Daiichi Sankyo Inc. (07/01/24)
    - Save Job - Related Jobs - Block Source
  • Sr. Director , CMC Quality Assurance

    Mitsubishi Chemical Group (Jersey City, NJ)
    …researching on real-world evidence, and creating hope for all facing illness. As a Senior Director of Quality Assurance CMC , you will be responsible ... activities related to the resolution of requests from the regulatory agencies. + Function as the CMC ...ability to inspire and motivate direct reports at the director level and below. + Ability to work independently… more
    Mitsubishi Chemical Group (06/15/24)
    - Save Job - Related Jobs - Block Source
  • Sr. Director - CMC Development

    Lilly (Philadelphia, PA)
    …and cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory , manufacturing, and supply chain teams, to ensure ... budget, and resource allocation, and provide regular updates to senior management. + Lead other tasks / projects as...projects and programs. + Advanced understanding of cGMPs and CMC regulatory requirements + Ability to manage… more
    Lilly (05/03/24)
    - Save Job - Related Jobs - Block Source
  • Senior Director - Analytical…

    Gilead Sciences, Inc. (Foster City, CA)
    …in more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES ... The Sr Director , Analytical Regulatory Science, is responsible for supervising a team of...leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure… more
    Gilead Sciences, Inc. (07/02/24)
    - Save Job - Related Jobs - Block Source
  • Senior Director , Regulatory

    Mitsubishi Chemical Group (Jersey City, NJ)
    …diseases, researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical, may be called ... plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs -...support marketing product claims. + Acts as liaison between Regulatory Affairs & CMC and other functional… more
    Mitsubishi Chemical Group (06/28/24)
    - Save Job - Related Jobs - Block Source
  • Senior Scientist/Associate Director

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
    Daiichi Sankyo Inc. (04/12/24)
    - Save Job - Related Jobs - Block Source
  • Senior Director , Commercial…

    Mitsubishi Chemical Group (Jersey City, NJ)
    …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs, is responsible for the ... marketed products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs,...Commercial Regulatory Affairs, in collaboration with Head, Regulatory Affairs and CMC -RA, will review and… more
    Mitsubishi Chemical Group (06/01/24)
    - Save Job - Related Jobs - Block Source
  • Senior Director , Purification…

    Gilead Sciences, Inc. (Foster City, CA)
    …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director , Purification Process Development - Pivotal & Commercial ... Biologics** The Senior Director of Purification Process Development for...strategy in partnership with organizations across Technical Development, Quality, Regulatory Affairs CMC , and Manufacturing. + Lead… more
    Gilead Sciences, Inc. (06/06/24)
    - Save Job - Related Jobs - Block Source
  • Director , Regulatory Affairs,…

    Ascendis Pharma (Palo Alto, CA)
    …and those of direct reports . Work is performed under direction of a Senior Regulatory Affairs professional Contribute to internal regulatory policies and ... The Director , Regulatory Affairs will be responsible...Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC more
    Ascendis Pharma (05/19/24)
    - Save Job - Related Jobs - Block Source
  • Senior Director , CMO…

    BeiGene (Emeryville, CA)
    **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... functional leadership (including but not limited to clinical Operation, Quality, Regulatory , CMC , and GRDS) to ensure alignment of organizations and prompt… more
    BeiGene (06/14/24)
    - Save Job - Related Jobs - Block Source
  • Executive Director , Regulatory

    Arvinas (New Haven, CT)
    …For more information, please visit www.arvinas.com . **Position Summary** The Executive Director , Global Regulatory Strategy is responsible for designing and ... knowledge, and interpersonal skills are required. This position reports to the Senior Vice President of Regulatory Affairs and can work remotely from… more
    Arvinas (06/28/24)
    - Save Job - Related Jobs - Block Source