• Merck & Co. (Rahway, NJ)
    …DescriptionWe are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... pipeline and drive our strategic priorities.Summary, Focus and PurposeThe Senior Principal Scientist - Regulatory Affairs...Focus and PurposeThe Senior Principal Scientist - Regulatory Affairs Liaison is responsible for development… more
    HireLifeScience (10/31/24)
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  • Aequor (Newbury Park, CA)
    …Global Regulatory Lead to manage GRT interactions The responsibilities of the Regulatory Affairs Senior Associate position are: Assist US Regulatory ... Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization. To coordinate and execution of US regulatory submissions with… more
    HireLifeScience (11/01/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... Experience in the pharmaceutical industry7 or More Years with direct regulatory affairs experience, including experience in regulatory submissions in… more
    HireLifeScience (10/01/24)
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  • Aequor (Thousand Oaks, CA)
    …experience with the Six Sigma methodology, process mapping and project management experience. Regulatory affairs knowledge will be considered. Any Regulatory ... a later time, if additional support is needed for the PST time zone. CW Senior Associate role within RIMS Team (GRAAS Organization). In order to support our team's… more
    HireLifeScience (10/31/24)
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  • Merck & Co. (Rahway, NJ)
    Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance ... our pipeline and drive our strategic priorities.The Director, Principal Scientist - Regulatory Affairs Liaison is responsible for development and implementation… more
    HireLifeScience (10/31/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and ... 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 (11/02/24)
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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 review ... 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 (10/31/24)
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  • Merck & Co. (Rahway, NJ)
    …Description of Position- This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). ... revised regulations, final guidance and standards.Provide strategic advice to senior management on CMC regulatory matters based...strategic advice to senior management on CMC regulatory matters based on health authority feedback and global… more
    HireLifeScience (10/25/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …Internally, they may partner with the Local and Global Clinical Operations, regulatory affairs , medical affairs , legal, communications, compliance, etc. ... 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 (10/31/24)
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  • Merck & Co. (Rahway, NJ)
    …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May… more
    HireLifeScience (10/23/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
    HireLifeScience (10/22/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. Position is ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in… more
    HireLifeScience (09/20/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …Oncology Business Unit/US Oncology Business Division (including, for example, Medical Affairs , Sales, Marketing, Market Access, etc.) including, but not limited to, ... areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside...counsel and direction to other members of the Legal Affairs Department as well as serving as a mentor… more
    HireLifeScience (10/19/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …as is required. Provides appropriate counsel and direction to other members of the Legal Affairs Department as well as serving as a mentor in order to foster their ... Company and/or departmental expectations and goals as identified by senior management.Responsibilities- Lead drafting and negotiating contracts for commercial,… more
    HireLifeScience (11/02/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …Insights and Analytics, IT, Data Strategy, Commercial Excellence, Legal, Compliance, Privacy, Regulatory Affairs , and other relevant NNI departments to ensure ... with broader TA and asset plans Work collaboratively with medical, market access, regulatory , legal, compliance, privacy and public affairs functions to support… more
    HireLifeScience (10/04/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... at key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,) Effectively interacts… more
    HireLifeScience (10/23/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …the company, and (2) assist cross functional teams during and in preparation for regulatory inspections, and (3) provide updates to senior management on various ... projects, as assigned, and provides support to the Legal Affairs team. Will serve as the primary legal advisor...perform research and advise clients on legal, business and regulatory issues. This position will primarily support the US… more
    HireLifeScience (10/09/24)
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  • Tris Pharma (Monmouth Junction, NJ)
    …compliant communication between marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations, etc.)Collaborates ... hear from you.We are hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing team.The Senior Director,… more
    HireLifeScience (09/03/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …strategy align with regulatory requirements and compliance standards. Collaborate with regulatory affairs and compliance teams to navigate regulatory ... navigating the evolving landscape of healthcare and technology integration. This is a senior level strategic thinker who is leading a complex role in understanding… more
    HireLifeScience (10/02/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... development and/or life cycle activities Health Systems strategy: Collaborates with medical affairs and market access teams to inform a health systems strategy to… more
    HireLifeScience (09/06/24)
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