• Senior Manager, Global Regulatory

    Takeda Pharmaceuticals (Boston, MA)
    …activities. Proactively recognizes and contributes to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report ... to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Plan, execute and manage regulatory submissions for assigned… more
    Takeda Pharmaceuticals (07/08/25)
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  • Global Regulatory Affairs

    Sanofi Group (Framingham, MA)
    **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA Waltham, MA **About the Job** Are you ready to shape the future of ... we chase the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves as a… more
    Sanofi Group (09/19/25)
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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 ... products CMC science and manufacturing processes. + Knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes… more
    Lilly (09/03/25)
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  • Advisor/Senior Advisor Global

    Lilly (Indianapolis, IN)
    …need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical ... molecules and/or synthetic peptides, proteins or oligonucleotide. + Knowledge of global CMC regulatory requirements and guidelines for reporting post… more
    Lilly (07/22/25)
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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 ... synthetic molecule CMC drug development science(s). + Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and… more
    Lilly (10/01/25)
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  • Executive Director, Regulatory CMC

    Merck (Rahway, NJ)
    …Team. This Lead plays a critical role in driving alignment and execution globally across Global Regulatory Affairs CMC ( Global Regulatory ... This individual will be a senior member of the Regulatory Affairs CMC organization and... Regulatory Affairs Global Regulatory Policy and the Head of CMC more
    Merck (10/01/25)
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  • Director, Scientific Expert CMC

    Boehringer Ingelheim (Athens, GA)
    …product regulatory strategy in the Global Regulatory Affairs (RA) Chemistry, Manufacturing and Controls ( CMC ) function for pharmaceutical products in ... Delivers expert evaluations of potential licensing opportunities, offering comprehensive global CMC regulatory assessments to... standards governing BIAH products and processes. + Represents regulatory affairs as a key leader during… more
    Boehringer Ingelheim (09/12/25)
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  • GRA Device Lead (Director)

    Sanofi Group (Morristown, NJ)
    …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... and Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than 1800...perspective as a member of project specific cross functional global regulatory team (GRT) and is accountable… more
    Sanofi Group (07/15/25)
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  • Associate Director, Regulatory

    AbbVie (North Chicago, IL)
    …and company policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product ... CMC on teams such as product development, Global Regulatory Product Teams and Operations brand...initiatives internal to RA CMC . + Represents CMC regulatory affairs on project… more
    AbbVie (09/26/25)
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  • Global Head, BioAnalytics, CMC

    Sanofi Group (Framingham, MA)
    …non-viral LNPs), with teams in France, Germany and the USA. Reporting to the head of Global CMC Development, this highly visible role has the potential to make a ... **Job Title:** Global Head, BioAnalytics, CMC Development **Location**...and with other Sanofi functions (eg, Research, Quality Assurance, Regulatory Affairs , Manufacturing & Supply, Business Development).… more
    Sanofi Group (09/20/25)
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  • Senior Manager of Statistics- CMC

    Takeda Pharmaceuticals (Cambridge, MA)
    …+ Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement CMC strategies to enable data driven ... shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior...realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation,… more
    Takeda Pharmaceuticals (09/03/25)
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  • Post-Doctoral Fellow Regulatory

    Boehringer Ingelheim (Ridgefield, CT)
    …or more therapeutic areas covering multiple dosage forms while interacting effectively within Regulatory Affairs and across CMC stakeholder functions, as a ... Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs . This position will require the Fellow… more
    Boehringer Ingelheim (08/30/25)
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  • Director, Regulatory Affairs

    Sumitomo Pharma (Tallahassee, FL)
    …position of **Director Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... function as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
    Sumitomo Pharma (09/09/25)
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  • Sr. Manager of Regulatory Affairs

    ThermoFisher Scientific (Grand Island, NY)
    …Chemistry, or related field; advanced degree preferred + 7 years of experience in CMC regulatory affairs within the pharmaceutical industry + 1+ year ... (GMP) Safety Standards, Office **Job Description** The Sr. Manager, Regulatory Affairs - Drug Support Strategy is...regulatory standards + Provide strategic mentorship on applicable CMC regulatory submissions and support for customers… more
    ThermoFisher Scientific (09/20/25)
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  • Senior Manager, Global Regulatory

    Otsuka America Pharmaceutical Inc. (Atlanta, GA)
    …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
    Otsuka America Pharmaceutical Inc. (08/22/25)
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  • Senior Principal Regulatory Affairs

    Bausch + Lomb (Juneau, AK)
    …the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and marketed products across ... activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA,...Master degree preferred + Minimum of 8 years in Regulatory Affairs or relevant experience in a… more
    Bausch + Lomb (09/24/25)
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  • Senior Principal Regulatory Affairs

    Bausch + Lomb (Juneau, AK)
    …strategies across CMC and clinical/non-clinical, labeling, adpromo domains + Lead all CMC regulatory activities for IND, NDA and ANDA submissions and OTC ... Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and...Master's degree preferred + Minimum of 8 years in Regulatory Affairs with experience in the consumer… more
    Bausch + Lomb (09/24/25)
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  • Regulatory Affairs Specialist

    Actalent (Grand Rapids, MI)
    Job Title: Quality Assurance Associate Job Description The Regulatory Affairs Specialist plays a crucial role in overseeing regulatory affairs activities ... requirements to stakeholders to ensure compliance. + Provide regulatory CMC support and review client submissions...and maintain SOPs, work instructions, and related documentation for Regulatory Affairs . + Perform Regulatory more
    Actalent (10/04/25)
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  • Associate Director Regulatory

    Amneal Pharmaceuticals (Piscataway, NJ)
    …+ Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and ... balancing business benefits and risks. + Lead and Manage Global Regulatory Submission Activities: Oversee submission planning,...compliance with FDA, EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures… more
    Amneal Pharmaceuticals (08/15/25)
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  • Senior Director Global Regulatory

    Lilly (Indianapolis, IN)
    …life better for people around the world. **Purpose:** The purpose of the Senior Director, Global Regulatory Affairs , Global Regulatory Lead (GRL) ... The GRL builds and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC...and regulatory excellence attributes as described in Global Regulatory Affairs white papers.… more
    Lilly (09/03/25)
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