• Unknown (Indianapolis, IN)
    …least 15 years' experience in large pharma and CMOs. Technical proficiency in CMC development and manufacturing, regulatory expertise, and a proven track record ... Executive Director or Vice President, Commercial CMC About the Company Industry leading open-access biologics technology platform Industry Pharmaceuticals Type… more
    job goal (12/05/25)
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  • Unknown (Indianapolis, IN)
    …disease oncology immtacs immune system hiring biologics autoimmune jobs scientists regulatory affairs and cmc biotechnology cancer infectious diseases autoimmune ... of publications and medical information teams. A strong commitment to ethical, regulatory , and scientific standards is essential, as is the ability to drive… more
    job goal (12/05/25)
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  • Unknown (Indianapolis, IN)
    …disease oncology immtacs immune system hiring biologics autoimmune jobs scientists regulatory affairs and cmc biotechnology cancer infectious diseases autoimmune ... diseases t cell receptor immunotherapy immtax immtac immtav and immtaai About the Role The Company is seeking a Vice President for Corporate Business Development to play a pivotal role in the strategic growth of the organization. The successful candidate will… more
    job goal (12/05/25)
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  • Unknown (Indianapolis, IN)
    …of radiolabeling and radioisotope production, ensuring strict adherence to GMP and CMC regulations. The Vice President will also be responsible for setting the ... and presentation skills, a deep understanding of GMP and CMC regulations, and a passion for innovation in the...to staying abreast of the latest scientific advancements and regulatory changes, and will have the opportunity to represent… more
    job goal (12/05/25)
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  • CMC Regulatory Affairs…

    Parexel (Indianapolis, IN)
    …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's ... regulatory leads in developing contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional project meetings and… more
    Parexel (10/11/25)
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  • Senior Specialist, Digital CMC…

    Merck (Indianapolis, IN)
    …development through commercialization, with practical insight into how these operations generate CMC regulatory content + Understanding of CMC operations, ... in business process mapping, gap analysis, and workflow optimization for CMC / regulatory authoring. + Practical knowledge of content models/structured content,… more
    Merck (12/02/25)
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  • Senior Manager, CMC Global…

    Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
    …or continued marketing. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications (eg, ... of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure… more
    Otsuka America Pharmaceutical Inc. (12/02/25)
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  • Associate Director, Regulatory Affairs…

    Sumitomo Pharma (Indianapolis, IN)
    …of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions ... highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global … more
    Sumitomo Pharma (10/11/25)
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  • Senior Principal Regulatory Affairs…

    Bausch + Lomb (Indianapolis, IN)
    …in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions. + ... business outcomes. **Responsibilities:** + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical/non-clinical, labeling, adpromo… more
    Bausch + Lomb (12/06/25)
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  • Sr. Director - Global Regulatory Lead…

    Lilly (Indianapolis, IN)
    …drug development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area neuroscience ... and regional/local affiliate requirements. The GRL creates and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC , GRA-Devices, and… more
    Lilly (11/06/25)
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