• Merck & Co. (Rahway, NJ)
    Regulatory Affairs Compliance , Regulatory Compliance , Regulatory Labeling, Regulatory Operations , Regulatory Submissions, Strategic ... full-time Business System Associate for the Labeling Operations area within the GRACS Regulatory Innovation...design improvement opportunities within the Support Model to reduce compliance risk and increase efficiency for the Support Team… more
    HireLifeScience (07/26/25)
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  • Merck & Co. (Upper Gwynedd, PA)
    …(BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical ... Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...Process Development, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory more
    HireLifeScience (07/19/25)
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  • Insmed Incorporated (San Diego, CA)
    …program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to ... transfers and mentoring junior staff. Maintaining laboratory equipment, ensuring safety and regulatory compliance , and supporting audits are also part of the… more
    HireLifeScience (07/21/25)
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  • Eisai, Inc (Exton, PA)
    …Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of established ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and...documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director… more
    HireLifeScience (05/29/25)
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  • Merck & Co. (Durham, NC)
    …excellence in Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director, External Manufacturing Operations will also assist in ... contact for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a… more
    HireLifeScience (05/20/25)
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  • Merck & Co. (Durham, NC)
    …Production Operations , Production Support, Project Management, Regulatory Compliance , Teamwork, Training and Development-Preferred Skills:Leadership, ... questionnaire, blood test, chest x-ray Position Responsibilities:This role reports to an Operations Associate Director and supports the product transfer for a… more
    HireLifeScience (07/29/25)
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  • Merck & Co. (Rahway, NJ)
    …matters.Review process change requests and deviation reports while ensuring regulatory compliance .Education and Minimum Requirements:Bachelor's degree in ... Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance , Root Cause Analysis (RCA), Stakeholder… more
    HireLifeScience (07/25/25)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
    HireLifeScience (07/26/25)
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  • Merck & Co. (Rahway, NJ)
    …Experience with sterile GMP facility startup.Knowledge of Investigational drug regulatory requirements.Understanding of Clinical Supply Chain Operations .Current ... in Rahway, New Jersey.The Sterile Process Engineer role at the Associate Director level will leverage the individual's leadership, technical, and communication… more
    HireLifeScience (07/11/25)
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  • Merck & Co. (Rahway, NJ)
    …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will be… more
    HireLifeScience (07/17/25)
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  • Merck & Co. (Rahway, NJ)
    …Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate...clinical supply planning and incorporate them into the team's operations . - Focus on Customers & Patients. - Make… more
    HireLifeScience (07/24/25)
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  • Merck & Co. (North Wales, PA)
    …with partners, vendors, and vendor management team . Review and provide clinical operations input into relevant clinical documents such as the protocol and other ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… more
    HireLifeScience (07/25/25)
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  • Eisai, Inc (Nutley, NJ)
    …exchange.Maintain scientific credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant ... your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education...independent medical education and symposia.Work with strategic planning & operations to manage the Global MSL projects budget by… more
    HireLifeScience (06/28/25)
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  • Twist BioScience (South San Francisco, CA)
    …that all products processed, packaged, stored, and distributed are manufactured in compliance with all Regulatory , Customer, and Twist requirements. In this ... The QC Associate II will be responsible for the implementation...the production laboratory. He/she will work closely with the operations team to monitor the quality of Twist DNA… more
    HireLifeScience (06/03/25)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams.Responsibilities: Study Strategy:… more
    HireLifeScience (05/13/25)
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  • Merck & Co. (Rahway, NJ)
    …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areasExperience… more
    HireLifeScience (07/24/25)
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  • Aequor (Hicksville, OH)
    …etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and ... breaks.Job Purpose Able to perform various inspecting, labelling and packaging operations . Tends machines that perform one or more packaging functions, such… more
    HireLifeScience (07/19/25)
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  • Aequor (Thousand Oaks, CA)
    …new technologies and ensure smooth integration into new and/or modified processes Regulatory Compliance and Quality Assurance: Ensure all data management ... and reduce hand offs. Collaborate with cross-functional teams (clinical operations , site management, biostatistics, stats programming, TA) to optimize trial… more
    HireLifeScience (07/03/25)
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  • Santander Holdings USA Inc (Boston, MA)
    …for identifying, assessing, and managing operational risks associated with digital payments operations , ensuring compliance with regulatory requirements, and ... Senior Digital Payments Risk Management Associate Country: United States of America Your Journey...risk assessment and oversight for electronic payments projects, ensuring compliance with regulatory requirements, Payment Systems Risk… more
    Upward (07/28/25)
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  • Ares Management Corporation (Los Angeles, CA)
    …Job Description The Ares Compliance Department oversees and manages Ares' global regulatory compliance and ethics program. Under the leadership of the Chief ... Compliance and Regulatory Officer, the ...Ares' Global Anti-Money Laundering and Counter-Terrorism Financing Program; and Compliance Operations , which oversee the department's operational… more
    Upward (07/28/25)
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