• Merck & Co. (North Wales, PA)
    Job DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic ... oncology pharmaceutical products. Provides innovative approaches to resolve complex regulatory issues and increase speed to patients.ResponsibilitiesCDx development: Provide… more
    HireLifeScience (03/01/24)
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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 ... Affairs , Gene Therapy Developing innovative therapies is one of the most challenging, most essential, and personally rewarding fields in science. And there’s something special about working at Astellas. It’s reflected in our focus on the people we serve,… more
    HireLifeScience (01/14/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, 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 (03/19/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support...of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines… more
    HireLifeScience (03/03/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and immune disorders. Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's ... regulatory group in internal and external development project meetings....guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input with feedback… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, 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 (02/23/24)
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  • Merck & Co. (North Wales, PA)
    Job DescriptionReports to the Director /Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
    HireLifeScience (03/01/24)
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  • Eisai, Inc (NJ)
    …difference. If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs ... key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial… more
    HireLifeScience (02/14/24)
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  • Eisai, Inc (Nutley, NJ)
    …this is your profile, we want to hear from you. Job Summary The Associate Director , Global Medical Affairs will provide medical leadership for medical affairs ... key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial… more
    HireLifeScience (01/25/24)
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  • Eisai, Inc (Nutley, NJ)
    …If this is your profile, we want to hear from you. The Associate Director , Digital Innovation and Omnichannel Engagement will be responsible for the direction and ... management of digital strategy, effectiveness and innovation initiatives supporting US Medical Affairs and Research & Development. The person in this role will drive… more
    HireLifeScience (02/07/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …More Years Pharmaceutical industry and Regulatory operations required.4 or More Years regulatory affairs including filing NDA and sNDA. BLA filing to FDA ... other research areas centered around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is… more
    HireLifeScience (03/25/24)
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  • Merck & Co. (Rahway, NJ)
    …(RPP) organization, which operates within the larger framework of Global Regulatory Affairs , Clinical Safety, and Pharmacovigilance (GRACS), Operations, Process, ... Job DescriptionThe Regulatory Project Manager (RPM) is a key member...distinct roles that contribute to the efficient management of regulatory projects.- Position Description/Summary The RPM plays a crucial… more
    HireLifeScience (03/23/24)
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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 ... independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include… more
    HireLifeScience (03/27/24)
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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)
    …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...ready to make a difference? The Position The Executive Director , Real World Evidence (RWE), is responsible for assuring… more
    HireLifeScience (03/18/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs , Regulatory Affairs and other NNI skill areas. ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
    HireLifeScience (03/15/24)
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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 Access -Our Oncology access team is dedicated to… more
    HireLifeScience (03/16/24)
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  • Merck & Co. (Rahway, NJ)
    …- Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... entire cycle of clinical development,-including-study design, placement, monitoring, analysis, regulatory reporting, and publication.-- - Specifically, the Director more
    HireLifeScience (03/05/24)
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  • Merck & Co. (Rahway, NJ)
    …cross-functional collaboration with business development, discovery, clinical development, medical affairs , regulatory , market access and key countries.- ... position as a sustainable innovation engine for the coming decade. The Director , Global Marketing Immunology Pipeline development is a key leadership role… more
    HireLifeScience (03/16/24)
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