• Auditing & Compliance Director - Software as…

    Wolters Kluwer (New York, NY)
    …renewals, new product registrations, and product change registrations. + Ensure regulatory submissions are well-organized, scientifically accurate, high quality, ... develop internal SOPs, WIs, and policies. + Continuously pursue regulatory knowledge to gain expertise in product submissions... regulatory knowledge to gain expertise in product submissions and regulatory topics. + Coach and… more
    Wolters Kluwer (06/11/25)
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  • Regulatory Analyst, Medicare

    Healthfirst (NY)
    …on developing significant marketing documents, assigning material IDs, and tracking submissions to regulatory agencies for status including approvals/denials. + ... marketing, educational, and ad hoc material reviews including assisting the Regulatory Affairs Manager by reviewing, finalizing, submitting, and tracking approvals… more
    Healthfirst (06/27/25)
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  • AVP, Financial Regulatory Rules…

    Citigroup (Queens, NY)
    …Performs day-to-day and ad-hoc activities related to the efficient processing of US regulatory capital policy inquiry submissions . + Supports the execution and ... The Financial Regulatory Rules Interpretation role is a position within...the CBNA CFO and Finance Transformation Organization in the Regulatory Capital Policy Group Process & Controls Team (RCPG… more
    Citigroup (07/26/25)
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  • Associate Director, Biostatistics

    Pfizer (New York, NY)
    …publishing manuscripts through co-authorship. The candidate may also provide support in regulatory submissions including responses to regulatory queries. ... + Provide scientifically rigorous statistical input into project development plans, regulatory submissions , interpretation of statistical results, study design,… more
    Pfizer (06/14/25)
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  • Director, Global Program Manager

    Pfizer (New York, NY)
    …scope. + Provides operational excellence, planning, and execution leading to successful regulatory submissions and approvals. + Provides support to the team ... sub-committees and steering committees, in particular the joint development committee. ** Submissions ** + Provides comprehensive project management for regulatory … more
    Pfizer (07/26/25)
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  • Asst Dir, Qual & Reg Assr, Clinical Trials

    University of Rochester (Rochester, NY)
    …objectives required. + Comprehensive knowledge of GCP and experience in managing regulatory submissions and inspections. Extensive knowledge of GCP standards, ... EMA, etc.) and GCP standards. + Serves as the primary liaison for regulatory agency interactions, including audits, inspections, and submissions . + Monitors,… more
    University of Rochester (07/29/25)
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  • Licensing & Registrations Manager

    Excellus BlueCross BlueShield (Rochester, NY)
    …of regulatory notices and bulletins. * Maintains corporate records regarding regulatory submissions , such as original and soft copies of company licenses ... be responsible for assisting with key aspects of the companies' regulatory licensing and registration compliance functions. Essential Accountabilities: * Researches,… more
    Excellus BlueCross BlueShield (07/25/25)
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  • Director, Biostatistics

    Pfizer (New York, NY)
    …other statisticians, study managers, alliance partner colleagues - for assigned studies and regulatory submissions . + Provide input to the Statistics Group Lead ... result interpretation, and providing statistical support and leadership in global regulatory submission activities, as well as implementing new initiatives and… more
    Pfizer (06/14/25)
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  • Vice President, Global Patient Safety Operations

    Regeneron Pharmaceuticals (Tarrytown, NY)
    …expertise and guidance to cross-functional teams to support product development, regulatory submissions , and post-marketing activities in the areas of ... expertise and mentorship to cross-functional teams to support product development, regulatory submissions , and post-marketing activities. + Establish and ensure… more
    Regeneron Pharmaceuticals (06/03/25)
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  • Senior Medical Director, Clinical Development,…

    Regeneron Pharmaceuticals (Tarrytown, NY)
    …Operational Leads to guide and execute clinical development strategies and subsequent regulatory submissions . This role requires a high-performing and highly ... (eg, Investigators' Brochure, protocol, study report, clinical components of regulatory submissions , safety related documents). Develops written responses… more
    Regeneron Pharmaceuticals (06/10/25)
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