• Astellas (Westborough, MA)
    …Manager, Cell/Gene Therapy Manager CMC Regulatory Affairs, Gene Therapy Associate Director CMC Regulatory Affairs, Gene Therapy Developing ... exciting opportunities located at our Westborough, MA site: Research Associate II, Analytical Development Senior Project Manager, Technical Operations...Project Manager, Technical Operations Senior CMC Regulatory Affairs… more
    HireLifeScience (01/14/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …or New Modality) team.- Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses ... (mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a… more
    HireLifeScience (03/12/24)
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  • Novo Nordisk Inc. (Boulder, CO)
    …quality, cost & timely completion of all validation deliverables. Relationships Associate Director . Essential Functions Perform, review & approve ... new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi… more
    HireLifeScience (03/23/24)
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  • Senior Associate Director

    Boehringer Ingelheim (Ridgefield, CT)
    …programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Director , US Product CMC Regulatory Affairs is responsible for the ... and post marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory Affairs acts as primary internal contact for all US… more
    Boehringer Ingelheim (03/16/24)
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  • Director , CMC Industry…

    Regeneron Pharmaceuticals (Troy, NY)
    The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance ... all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory...health, environment or politics or related degree and: + Associate Director : 15+ years of related experience… more
    Regeneron Pharmaceuticals (03/11/24)
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  • Associate Director CMC RA

    Amicus Therapeutics (Marlow, OK)
    Associate Director CMC RA Location Marlow, UK Requisition ID 2246 # of openings 1 Apply Now ... (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1290) Job Brief Associate Director CMC RA Amicus Therapeutics is a… more
    Amicus Therapeutics (03/12/24)
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  • AD Drug Substance Analytic - External Alternative…

    Boehringer Ingelheim (Ridgefield, CT)
    …advancement of NCE-like Alternative Medicinal Therapeutic Product (ATMP) projects. The Associate Director , Analytical/QC will be responsible for leading ... **Description** The EACD department develops new CMC paradigms for more effective and efficient NCE...(Continued)** + Ensure compliance with all required training, safety, regulatory , HR, intellectual property, GMP's and GLP's (where applicable),… more
    Boehringer Ingelheim (03/06/24)
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  • Associate Director

    Teva Pharmaceuticals (West Chester, PA)
    Associate Director , Regulatory Affairs - West Chester, PA Date: Mar 26, 2024 Location: West Chester, United States, 1938 Company: Teva Pharmaceuticals Job ... difference with. **How you'll spend your day** As the Associate Director , Regulatory Affairs you...of the regional, clinical and Chemistry Manufacturing and Controls ( CMC ) regulatory strategies with the overall global… more
    Teva Pharmaceuticals (02/27/24)
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  • Senior Scientist/ Associate Director

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
    Daiichi Sankyo Inc. (01/12/24)
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  • Associate Director

    J&J Family of Companies (Washington, DC)
    Associate Director , Regulatory Affairs - 2406166277W **Description** Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of ... Companies, is recruiting for an Associate Director , Regulatory Affairs. This...alignment with NA regional teams, Chemistry, Manufacturing, and Controls ( CMC ), commercial strategies, and the Target Product Profile. +… more
    J&J Family of Companies (03/22/24)
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  • Associate Director

    AbbVie (South San Francisco, CA)
    …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description We are currently seeking a Regulatory Affairs Associate Director to join our growing ... sciences, chemistry, or related discipline. Advanced degree preferred. . Associate Director - 5 - 7 years...and understanding of the regulatory environment. International regulatory experience required. Director - 7-10 years… more
    AbbVie (03/18/24)
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  • Regulatory Strategist - Associate

    Sanofi Group (Bridgewater, NJ)
    **Main responsibilities:** + Leads the US regulatory activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global ... Regulatory Lead (GRL), the Regulatory Specialist leverages...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… more
    Sanofi Group (03/07/24)
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  • Associate Director / Director

    Amicus Therapeutics (Princeton, NJ)
    Associate Director / Director Technical Development & Manufacturing, Contractor Location Princeton, NJ Requisition ID 2237 # of openings 1 Apply Now ... (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1281) Associate Director / Director Technical Development &… more
    Amicus Therapeutics (02/28/24)
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  • Associate Director , Clinical Supply…

    Lilly (IN)
    …to make life better for people around the world. **Position Summary:** The Associate Director , Clinical Supply Management has responsibility for the end to ... team members across functions including but not limited to clinical operations, CMC , regulatory affairs, and QA. + Working knowledge of cGMP's (CFR/ICH) and GCP… more
    Lilly (02/27/24)
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  • Associate Director , Biostatistics,…

    Ascendis Pharma (Palo Alto, CA)
    …of the business, from drug development to marketing. Position Summary The Associate Director of Biostatistics will provide statistical leadership, oversight, ... and activities at CROs. Additional analysis support of non-clinical / biomarker / CMC data and derive insight to contribute to Ascendis' scientific research may… more
    Ascendis Pharma (03/10/24)
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  • Senior Associate Director

    Boehringer Ingelheim (North Brunswick, NJ)
    …Ingelheim has a career opportunity developing pharmaceutical products as a Senior Associate Director , Analytical Development. We are looking for an individual ... materials, to support clinical programs and the preparation of regulatory packages for international product registration activities. In collaboration with… more
    Boehringer Ingelheim (02/09/24)
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  • Associate Director - Chemical…

    Novo Nordisk (Watertown, MA)
    …drug substance and resolve technical issues or deviations + Author and review relevant CMC sections for US and ex-US regulatory filings, including NDAs + Work ... Development - Boston and will work closely with other functions of CMC drug development, including Drug Product, Analytical Sciences, Quality Assurance, and Supply… more
    Novo Nordisk (03/12/24)
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  • Associate Director , Product…

    Bristol Myers Squibb (New Brunswick, NJ)
    …Product Development (DPD)** Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve ... internal engine of innovation includes unrivaled industry leading expertise in CMC development of small molecules, protein biotherapeutics, protein degraders, and… more
    Bristol Myers Squibb (03/23/24)
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  • Associate Director - Quality Control

    Novo Nordisk (Watertown, MA)
    …The Analytical Sciences and Quality Control group is a core pillar of our dynamic CMC drug development team. This role is critical in development of assets in our ... rare-disease, small molecule portfolio. Relationships Reporting to the Director , Analytical Sciences, this position works closely with other functions in CMC more
    Novo Nordisk (02/21/24)
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