• Sr. Director - Global Regulatory Affairs…

    Lilly (Indianapolis, IN)
    …supervision. The Sr. Director must also develop mutually productive relationships with the FDA Office of Prescription Drug Promotion (OPDP), Lilly components and ... across GRA** + Partnering with Therapeutic Directors from GRA to consider FDA Review Division perspectives and relevant regulatory history in advertising… more
    Lilly (08/08/25)
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  • Senior Manager, Regulatory Operations

    Sumitomo Pharma (Indianapolis, IN)
    …Manages the planning, tracking, compiling, quality checking and submission of required FDA Submissions (eg Establishment Registrations, Drug Product Listings). + ... and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and… more
    Sumitomo Pharma (07/18/25)
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  • Director, Regulatory Advertising…

    Sumitomo Pharma (Indianapolis, IN)
    …a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, guidance ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
    Sumitomo Pharma (07/08/25)
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  • Senior Manager, Global Regulatory Affairs

    Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
    … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory more
    Otsuka America Pharmaceutical Inc. (06/19/25)
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  • Senior Director, Global Regulatory Affairs…

    Lilly (Indianapolis, IN)
    …and updating approved global product registrations for drug substances and drug products. + Utilizes specialized scientific and regulatory expertise to ... documents. + Participates in health authority interactions reviewed by FDA assessment offices and other global regulators, as needed....knowledge in drug development including API, or Drug Product or Analytical + Demonstrated CMC regulatory more
    Lilly (06/25/25)
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  • Senior Director - Drug Supply Chain…

    Lilly (Indianapolis, IN)
    …the world. We are seeking a strategic and experienced Senior Director of Drug Supply Chain Security Act (DSCSA) Compliance & Quality to lead our enterprise-wide ... This role will be responsible for ensuring the integrity, traceability, and regulatory compliance of our pharmaceutical supply chain, while also driving continuous… more
    Lilly (07/08/25)
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  • Lead Technology Product Manager-Commercial…

    Wolters Kluwer (Indianapolis, IN)
    …metrics. * Leverage knowledge of US healthcare government and regulatory published drug information and policy data sources (CMS, FDA , etc.) covering drug ... **Lead Technology Product Manager** - Commercial Drug Information This role follows a hybrid model,...drug clinical attributes, pricing and reimbursement data, and regulatory classifications-and how these data types are used in… more
    Wolters Kluwer (07/18/25)
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  • Associate Director, MSAT, Downstream Drug

    Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
    …potentially formulation/fill-finish operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
    Otsuka America Pharmaceutical Inc. (07/18/25)
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  • Clinical Research Physician -- Development

    Lilly (Indianapolis, IN)
    …+ Supports/assists in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), ... reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the… more
    Lilly (07/16/25)
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  • Clinical Research Physician - Development

    Lilly (Indianapolis, IN)
    …Support/ assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), ... reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the… more
    Lilly (07/25/25)
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