• Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …rare diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... RA strategy into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance bodies.Serve as a… more
    HireLifeScience (03/28/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience… more
    HireLifeScience (02/23/24)
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  • ProKatchers (Gaithersburg, MD)
    Job Description: As a Regulatory Affairs professional within client, you will play a key role in channeling our scientific capabilities to make a positive impact ... on changing patients' lives. In Regulatory Affairs , our teams influence the development...leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of… more
    JobGet (03/07/24)
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  • Merck & Co. (North Wales, PA)
    …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... Job DescriptionThe Director , Regulatory Affairs Liaison,...release from our company to external agencies and investigators.Represents Global Regulatory Affairs (GR) within… more
    HireLifeScience (03/01/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …including colleagues in Lexington, MA and Princeton, NJ, as well as the broader Global Regulatory Affairs (GRA) organization Serves as an influential leader ... ready to make a difference? The Position We are seeking a Senior Director , Global Regulatory Portfolio Lead who will be responsible for developing,… more
    HireLifeScience (03/29/24)
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  • Merck & Co. (North Wales, PA)
    …corporate standards and policies and business objectives.Actively- participate in labeling and global regulatory team meetings to ensure support for anticipated ... Job DescriptionReports to the Director /Senior Director in the Office of...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
    HireLifeScience (03/03/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …centered around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, ... CDx RA Policy and Intelligence: Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these changesAssessing… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier ... of Dossier Planning will report to Head of Global Regulatory Operations and be an active...and Regulatory operations required.4 or More Years regulatory affairs including filing NDA and sNDA.… more
    HireLifeScience (03/25/24)
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  • Astellas (Westborough, MA)
    …Senior CMC Regulatory Affairs Manager, Cell/Gene Therapy Manager CMC Regulatory Affairs , Gene Therapy Associate Director CMC Regulatory ... business with ethics and integrity, so that we can continue to change global health for the better. Explore these exciting opportunities located at our Westborough,… more
    HireLifeScience (01/14/24)
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  • Merck & Co. (Rahway, NJ)
    …and Publishing (RPP) organization, which operates within the larger framework of Global Regulatory Affairs , Clinical Safety, and Pharmacovigilance (GRACS), ... plays a crucial role in guiding and advancing projects by translating global regulatory strategy into actionable plans at the asset level. This individual acts… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (North Wales, PA)
    …Annex 11, Good Laboratory and Clinical practices, Computer Systems Validation, and other global regulatory requirements that impact IT systems in the R&D and ... and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high-quality standards.- Product managers must possess… more
    HireLifeScience (03/29/24)
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  • Merck & Co. (North Wales, PA)
    …working effectively with cross-functional partners including research and development, medical affairs , regulatory affairs , Business Development & Licensing, ... Job DescriptionWe are currently recruiting for an Executive Director , Oncology Portfolio Strategy, Global Market...to shape product profiles using the access lens -Across global functions including payer engagement, policy, medical affairs more
    HireLifeScience (03/16/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …the Global Oncology Value, Access, and Pricing (GOVAP) department. The Associate Director , Global Oncology RWE Generation will report directly to the ... and retaining institutional memory within Daiichi Sankyo. The Associate Director , Global Oncology RWE Generation will work...this role include Regional HEOR/RWE and Market Access teams, Global Oncology Medical Affairs (GOMA) and its… more
    HireLifeScience (03/12/24)
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  • Merck & Co. (Rahway, NJ)
    …our position as a sustainable innovation engine for the coming decade. The Director , Global Marketing Immunology Pipeline development is a key leadership role ... cross-functional collaboration with business development, discovery, clinical development, medical affairs , regulatory , market access and key countries.-… more
    HireLifeScience (03/16/24)
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  • Merck & Co. (North Wales, PA)
    …activities Collaborate with key stakeholders across the enterprise, including Medical Affairs , Manufacturing, Global Marketing, Global digital data ... an experienced, motivated, and passionate talent to serve as the Executive Director , US Commercial Leader (USCL), for our investigational novel treatment for adults… more
    HireLifeScience (03/29/24)
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  • Merck & Co. (North Wales, PA)
    …are seeking a highly experienced and dynamic individual to join our team as the Global Director HIV Marketing. In this role, you will be responsible for leading ... different markets worldwide.Collaborate closely with cross-functional teams, including medical affairs , market access, regulatory , manufacturing, and alliance… more
    HireLifeScience (03/08/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …Vice President, Clinical Data Science & Evidence (CDSE) in Clinical, Medical and Regulatory Affairs (CMR) and has broad responsibility for managing multiple ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...with leadership in CMR, Market Access, Marketing, Legal, Public Affairs , Global Market Access, and Global more
    HireLifeScience (03/18/24)
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  • Novo Nordisk Inc. (Chicago, IL)
    …TA priorities and business needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's directly into the TA head). ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
    HireLifeScience (03/20/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …access, commercial insights and analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent.… more
    HireLifeScience (03/27/24)
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