• Astellas (Westborough, MA)
    …Research Associate II, Analytical Development Senior Project Manager , Technical Operations Senior CMC Regulatory Affairs Manager , Cell/Gene Therapy ... Manager CMC Regulatory Affairs , Gene Therapy Associate Director CMC Regulatory Affairs , Gene Therapy Developing innovative therapies is one of… more
    HireLifeScience (01/14/24)
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  • Aequor (Thousand Oaks, CA)
    …a mixed background not just lab but manufacturing and process development. This manager position within CMC will facilitate product development and global ... registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs… more
    HireLifeScience (03/22/24)
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  • Tris Pharma (Monmouth Junction, NJ)
    …This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs , CMC , New Products, Sales & Marketing, and ... in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ...input on deal terms and creation of relevant clinical, regulatory , and commercial scenarios Prepare clear and concise presentations… more
    HireLifeScience (03/25/24)
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  • Regulatory Affairs CMC Senior…

    Randstad US (Cambridge, MA)
    regulatory affairs cmc senior manager . + cambridge , massachusetts (remote) + posted march 1, 2024 **job details** summary + $75 - $86.54 per hour + ... effectively and expeditiously reach satisfactory resolution among all involved parties. skills: CMC , IND, Regulatory Affairs Operations, Submissions, ICH… more
    Randstad US (03/13/24)
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  • Manager , CMC Regulatory

    Teva Pharmaceuticals (West Chester, PA)
    …for maintaining and updating CMC sections of submissions for assigned products. As Manager CMC Regulatory Affairs you will also be responsible ... Manager , CMC Regulatory Affairs - West Chester, PA Date: Mar 26, 2024 Location: West Chester, United States, 19380 Company: Teva Pharmaceuticals Job Id:… more
    Teva Pharmaceuticals (02/27/24)
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  • Senior Manager , Regulatory

    BeiGene (Emeryville, CA)
    …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **the** **job:** . Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
    BeiGene (03/19/24)
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  • Manager CMC /CP Regulatory

    Regeneron Pharmaceuticals (Troy, NY)
    …for program-specific discussions, connect the dots across IOPS, proactively identify CMC regulatory issues and suggest appropriate strategies to mitigate ... **In this role, a typical day might include the following:** * Support CMC /Combination product development activities from a regulatory standpoint during early… more
    Regeneron Pharmaceuticals (03/28/24)
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  • Sr Manager , Regulatory CMC

    Pfizer (Pearl River, NY)
    …of activities, such as, but not limited to, preparing or authoring CMC regulatory investigational, commercial and post approval submissions, representing the ... help Pfizer develop and implement chemistry, manufacturing and control ( CMC ) regulatory strategies for large molecules and...of the principles and concepts in the area of regulatory affairs and comprehensive knowledge of other… more
    Pfizer (03/21/24)
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  • Manager , Regulatory CMC

    Pfizer (Collegeville, PA)
    …of activities, such as, but not limited to, preparing or authoring CMC regulatory investigational, commercial and post approval submissions, representing the ... and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Regulatory Affairs more
    Pfizer (03/21/24)
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  • Senior Manager , RA CMC

    AbbVie (North Chicago, IL)
    …YouTube and LinkedIn. Job Description The Senior Manager Regulatory Affairs , Chemistry, Manufacturing and Controls ( CMC ) works with internal and external ... policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product development,… more
    AbbVie (03/19/24)
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  • Regulatory Affairs Manager

    Randstad US (Chicago, IL)
    regulatory affairs manager iii....requirements skills: CMC , GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory ... 9 to 5 education: Bachelors responsibilities: + Provides strategic and operational Regulatory CMC expertise and support in cross-functional teams, working… more
    Randstad US (03/19/24)
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  • Manager , Regulatory Affairs

    Teva Pharmaceuticals (West Chester, PA)
    Manager , Regulatory Affairs - Biosimilars...CMC ) regulatory strategies with the global regulatory strategy. + The Manager will assist the ... The Manager is responsible for supporting the Regulatory Affairs strategic vision and regulatory...cooperation with the GRAST members (Regional Strategic Leads, Global Regulatory CMC lead, Global Strategic Labeling/ Ad… more
    Teva Pharmaceuticals (02/15/24)
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  • Manager , Regulatory Affairs

    Ascendis Pharma (Palo Alto, CA)
    …perspectives to all aspects of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for supporting and ... Alto, CA and reports directly to the Senior Director, Regulatory Affairs . Key Responsibilities + Responsible for.... Key Responsibilities + Responsible for strategic and operational regulatory input and support for cross functional ( CMC more
    Ascendis Pharma (03/17/24)
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  • Senior Manager , Regulatory

    Lauridsen Group Inc. (Ankeny, IA)
    The Senior Manager of Regulatory Affairs plays a crucial role in ensuring Proliant Health & Biologicals (PHB) products comply with local and international ... develop and implement regulatory strategies. The Senior Manager of Regulatory Affairs is...ensure alignment with overarching PHB business strategies. + Provide regulatory leadership with expertise in CMC and… more
    Lauridsen Group Inc. (02/08/24)
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  • Senior Manager , Regulatory

    Danaher Corporation (Washington, DC)
    …solutions that safeguard and improve human health. This position is part of the Regulatory Affairs & Compliance department located in Fargo, North Dakota and ... discoveries worldwide. You will be a part of the Regulatory Affairs & Compliance team and report...that regulatory requirements are satisfied. + Provide regulatory guidance (ie, CGMP and CMC compliance… more
    Danaher Corporation (02/17/24)
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  • Senior Manager Regional Regulatory

    CSL Behring (King Of Prussia, PA)
    …used to treat serious and often rare conditions. Could you be our next Senior Manager of Regional Regulatory Affairs ? This position is located in our ... regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC...GRA NA representative for assigned projects to the Global Regulatory Affairs Strategy Team (GRAST) to provide… more
    CSL Behring (02/01/24)
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  • Senior Director, Commercial Regulatory

    Mitsubishi Chemical Group (Jersey City, NJ)
    …the Senior Director, Commercial Regulatory Affairs , in collaboration with Head, Regulatory Affairs and CMC -RA, will review and assess all commercial ... hope for all facing illness. The Senior Director, Commercial Regulatory Affairs , is responsible for the development...and non-promotional materials. + Collaborates closely with the PMRC Manager and other members to quickly resolve issues that… more
    Mitsubishi Chemical Group (03/01/24)
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  • Senior Manager , Global Regulatory

    AbbVie (Madison, NJ)
    …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager , Global Regulatory Strategy, US & Canada, AbbVie Inc., Madison ... product(s) with multiple driver indications within a Therapeutic Area and support the Manager , Global Regulatory Lead (GRL), Associate Director, or Director, in… more
    AbbVie (03/26/24)
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  • Financial Compliance Data Manager II

    LA Care Health Plan (Los Angeles, CA)
    …(OMT) Online Monitoring Tool (OMT) by Gorman) will also be updated and reported to Regulatory Affairs and Compliance (RAC) for support of CMS regulatory ... Financial Compliance Data Manager II Job Category: Accounting/Finance Department: Financial Compliance...to the Claims department to collect Medicare/ Cal MediConnect ( CMC ), Organization Determination, Appeals & Grievances (ODAG) data from… more
    LA Care Health Plan (02/10/24)
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  • Development Program Manager

    Encoded Therapeutics (South San Francisco, CA)
    …deliverables, and contributing to various cross-functional projects in areas such as CMC , Regulatory , Clinical, Medical Affairs , Patient Advocacy, and ... versatile individual to join our team as a Program Manager (level to be determined based on experience). In...with functional leads to coordinate cross-functional projects related to CMC , Regulatory , Clinical, Medical, Patient Advocacy and… more
    Encoded Therapeutics (01/14/24)
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