• 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 ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...for a Consultant level role, 7+ years for a Senior Consultant * Proven success in preparing regulatory more
    Parexel (10/11/25)
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  • Senior Advisor/Director, Global…

    Lilly (Indianapolis, IN)
    …who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC ... make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new medicines to… more
    Lilly (10/01/25)
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  • Senior Advisor/Director Global…

    Lilly (Indianapolis, IN)
    …them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use ... better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients… more
    Lilly (09/03/25)
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  • Advisor/ Senior Advisor Global…

    Lilly (Indianapolis, IN)
    …patients who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC ... life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to… more
    Lilly (10/21/25)
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  • CMC Regulatory Quality Advisor

    Lilly (Indianapolis, IN)
    …are determined to make life better for people around the world. **The purpose of the CMC Regulatory Quality Advisor role is to be the quality expert for their ... team.** **Primary Responsibilities:** **This position provides direct quality support to Global Regulatory Affairs (GRA), with a primary focus on the Chemistry,… more
    Lilly (11/14/25)
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  • Senior Principal Regulatory

    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. + ... preferred + Minimum of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work with medical device, cosmetics… more
    Bausch + Lomb (09/06/25)
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  • Associate Director, Regulatory

    Sumitomo Pharma (Indianapolis, IN)
    …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Global Regulatory Affairs (GRA) team based in the US....the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of … more
    Sumitomo Pharma (10/11/25)
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  • Senior Manager, Global Regulatory

    Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
    …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
    Otsuka America Pharmaceutical Inc. (11/20/25)
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  • Associate Director, Regulatory

    Sumitomo Pharma (Indianapolis, IN)
    …a dynamic, highly motivated, and experienced individual for the position of Associate Director Regulatory Affairs . The Associate Director is part of the Global ... Regulatory Affairs (GRA) team based in the...collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, clinical protocols/study reports,… more
    Sumitomo Pharma (11/20/25)
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  • Senior Director Global Regulatory

    Lilly (Indianapolis, IN)
    …to make life better for people around the world. **Purpose:** The purpose of the Senior Director, Global Regulatory Affairs , Global Regulatory Lead (GRL) ... regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participate in...for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable… more
    Lilly (11/06/25)
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