• Aequor (Thousand Oaks, CA)
    FULLY REMOTE The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that provides varying levels of product support to the ... What we are looking for: ? Desire to learn Regulatory Affairs CMC and global submission strategy;...Biopharmaceutical, Pharmaceutical or related scientific experience o OR o Associate degree and 6 years of either Regulatory more
    HireLifeScience (03/13/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late… more
    HireLifeScience (02/23/24)
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  • Eisai, Inc (Nutley, NJ)
    …solutions and drive best practices within Scientific Communications and Medical Affairs .Drive oversight, project management and delivery of digital ... If this is your profile, we want to hear from you. The Associate Director, Digital Innovation and Omnichannel Engagement will be responsible for the direction… more
    HireLifeScience (02/07/24)
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  • Merck & Co. (Rahway, NJ)
    Job DescriptionThe Regulatory Project Manager (RPM) is a key member of our company's Regulatory Planning and Publishing (RPP) organization, which operates ... within the larger framework of Global Regulatory Affairs , Clinical Safety, and Pharmacovigilance (GRACS),...at the asset level. This individual acts as a regulatory project management expert, ensuring alignment and… more
    HireLifeScience (03/23/24)
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  • Astellas (Westborough, MA)
    … 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 the most challenging, most… more
    HireLifeScience (01/14/24)
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  • Merck & Co. (Rahway, NJ)
    …collaborating with project teams, biomarker leaders, clinical operations, and regulatory affairs on the implementation of these assays in clinical ... are deployed in support of clinical trials. The candidate for this Associate Principal Scientist position should have strong technical expertise in molecular biology… more
    HireLifeScience (03/27/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... changes for portfolio biologics and determines filing strategies, provides expertise as regulatory CMC representative to project teams, and supports change… more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …team in the Global Oncology Value, Access, and Pricing (GOVAP) department. The Associate Director, Global Oncology RWE Generation will report directly to the Global ... well as building and retaining institutional memory within Daiichi Sankyo. The Associate Director, Global Oncology RWE Generation will work in close collaboration… more
    HireLifeScience (03/12/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and study protocols.This position independently manages relationships with internal (CSPV, Regulatory , Clinical, Medical Affairs , HEOR and other stakeholders to ... areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director, Pharmacoepidemiology position provides epidemiologic, methodological, and analytic… more
    HireLifeScience (03/14/24)
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  • Merck & Co. (Rahway, NJ)
    …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be… more
    HireLifeScience (03/09/24)
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  • Associate Manager, Regulatory

    J&J Family of Companies (Skillman, NJ)
    Associate Manager, Regulatory Affairs - 2407018181W **Description** Kenvue is currently recruiting for: ** Associate Manager, Regulatory Affairs ** ... more information, click here (https://www.youtube.com/watch?v=XhsbOsBiX\_M) . **Role reports to:** Associate Director, Regulatory Affairs **Location:**… more
    J&J Family of Companies (03/21/24)
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  • Manager/ Associate Director,…

    Boehringer Ingelheim (St. Joseph, MO)
    …benefit programs reflect Boehringer Ingelheim's high regard for our employees. As the Manager/ Associate Director, Regulatory Affairs Pharma Safety & Efficacy ... you will: Act as Regulatory Affairs (RA) team member in projects...with more senior RA team members to provide consistent regulatory advice to project teams regarding the… more
    Boehringer Ingelheim (01/26/24)
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  • Associate Director, Regulatory

    Gilead Sciences, Inc. (Foster City, CA)
    …make a direct impact. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global ... Regulatory Affairs organization and acts as a...oversees other team members representing RA Labeling on RA Project Teams, at cross-functional submission team meetings, and on… more
    Gilead Sciences, Inc. (03/28/24)
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  • Associate Director, Regulatory

    BD (Becton, Dickinson and Company) (Covington, GA)
    **Job Description Summary** As Associate Director, Regulatory Affairs , you will be responsible for managing a team that develops and executes the strategy ... with Legal and clinical team to ensure compliance with regulatory requirements. + Presents regulatory project...and regulation or guidance changes to Corporate Quality and Regulatory Affairs . International Regulatory more
    BD (Becton, Dickinson and Company) (01/09/24)
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  • Associate Director, Regulatory

    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...regulatory strategies, submissions and approvals for assigned biosimilar project (s) + Interface with project teams and… more
    Teva Pharmaceuticals (02/27/24)
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  • US Regulatory Affairs - GDP, RA,…

    System One (Florham Park, NJ)
    Position: CONTRACTOR -- US Regulatory Affairs - GDP, RA, Associate Location: Remote (East or Central Time Zone) Contract: 12mns Pay Rate: 25/hr - 35/hr This ... up and maintenance activities relevant to regulatory affairs , as needed. + Assist with project management activities for large regulatory submissions. +… more
    System One (03/06/24)
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  • 6 Month Sr. Regulatory Affairs

    Actalent (Valencia, CA)
    …Apply NOW This cutting age dental implant company is looking to hire a Regulatory affairs associate to their team. For Immediate consideration, please ... for human tissue bank products for US FDA and various States. Represent Regulatory Affairs on assigned project teams through all phases of product… more
    Actalent (03/23/24)
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  • Associate Director, Regulatory

    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 ... provides leadership in the strategic guidance and execution of regulatory concepts within cross - functional project ...Director - 5 - 7 years of experience in Regulatory Affairs (strong preference for experience in… more
    AbbVie (03/18/24)
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  • Associate Director Regulatory

    Abbott (St. Paul, MN)
    …catheters and software, vessel closure devices and peripheral stents. **The Opportunity** This ** Associate Director Regulatory Affairs ** will work on-site at ... Vascular Division. As a manager, the function of an Associate Director Regulatory Affairs is...produce and market new products. + Provides guidance on regulatory requirements and strategies to product development project more
    Abbott (03/20/24)
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  • Associate Director, Global…

    Gilead Sciences, Inc. (Foster City, CA)
    …Global TA Regulatory Liaisons is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across drug ... may lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA...or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. **EXAMPLE RESPONSIBILITIES:** + As… more
    Gilead Sciences, Inc. (03/19/24)
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