• Regulatory Affairs Manager

    ThermoFisher Scientific (Greenville, NC)
    …a crucial role in the development of novel and innovative medical devices?** The Regulatory Affairs Manager develops regulatory strategies and supports ... **Job Description** Join Thermo Fisher Scientific Inc. as a Clinical Trial Reg Affairs Manager ...as well as the preparation of marketing applications. The Regulatory Affairs Manager identifies and… more
    ThermoFisher Scientific (03/07/25)
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  • Manager , Regulatory Affairs

    Taiho Oncology (Princeton, NJ)
    Manager , Regulatory Affairs Strategy Princeton, NJ, USA Req #439 Wednesday, February 19, 2025 Looking for a chance to make a meaningful difference in the ... Position Summary: + ​​ The incumbent is responsible for supporting Regulatory Affairs activities (nonclinical, clinical and safety) for assigned… more
    Taiho Oncology (02/20/25)
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  • Sr Regulatory Affairs Manager

    Fujifilm (Santa Ana, CA)
    **Position Overview** We are hiring a Sr. Manager , Regulatory Affairs . The Sr. Manager , Regulatory Affairs will be responsible for ensuring that ... and various regulatory external and internal support as required. The Sr. Manager , Regulatory Affairs oversees and manages complete product lifecycle… more
    Fujifilm (02/07/25)
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  • Regulatory Affairs Program…

    Philips (Bothell, WA)
    …while serving the public access AED, EMS, military, and hospital market segments. In this Regulatory Affairs Program Manager role and as part of an agile ... workers who depend on these innovative life-saving solutions. The Regulatory Affairs Program Manager will...have a Minimum of a Bachelor's Degree (Required) in Regulatory Affairs , Biomedical Engineering, Clinical /Life… more
    Philips (03/14/25)
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  • Director, Clinical Regulatory

    Vera Therapeutics (Brisbane, CA)
    Title: Director, Clinical Regulatory Affairs Location: Brisbane About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical -stage biotechnology ... position is specifically responsible for the oversight of regional and global regulatory clinical submissions and to develop strategies to support therapeutic… more
    Vera Therapeutics (02/07/25)
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  • Senior Manager , Regulatory

    AbbVie (Irvine, CA)
    …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs US Advertising and Promotion - ... pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (eg regulatory affairs fellowship, Health Authority, ad promo, etc.) + Preferred… more
    AbbVie (01/10/25)
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  • Regulatory Affairs Manager

    Abbott (Pleasanton, CA)
    …working mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager ** to join Abbott's Heart Failure ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to...guidelines, policies and regulations + Ethical guidelines of the regulatory profession, clinical research and regulatory more
    Abbott (12/17/24)
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  • Manager , Global Regulatory

    Takeda Pharmaceuticals (Boston, MA)
    …for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Manager , Global Regulatory Affairs , Marketed Products **POSITION ... : Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs , Marketed...submissions; Provide strategic and tactical guidance to teams, including regulatory review of clinical trial documents and… more
    Takeda Pharmaceuticals (02/22/25)
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  • Regulatory Affairs Manager

    Amgen (Washington, DC)
    …Amgen team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Manager - US Regulatory Lead** **What you ... plans and local regulatory requirements. + Implementation of product-related regulatory strategies, Regulatory Affairs processes, and activity planning.… more
    Amgen (03/06/25)
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  • Associate Manager - Regulatory

    Novo Nordisk (Plainsboro, NJ)
    …ready to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical ... About the Department The Clinical , Medical and Regulatory (CMR) department...The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global… more
    Novo Nordisk (01/25/25)
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  • Regulatory Affairs Senior…

    Amgen (Washington, DC)
    …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Manager - Regional Regulatory Lead** **Live** ... do** Let's do this. Let's change the world. The Regulatory Affairs Senior Manager at... regulatory strategies. **Responsibilities:** + Implement the US regulatory plan and obtain and maintain Clinical more
    Amgen (03/04/25)
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  • Manager , Regulatory Affairs

    Regeneron Pharmaceuticals (Tarrytown, NY)
    The Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... following:** + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of… more
    Regeneron Pharmaceuticals (02/20/25)
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  • Manager , Global Regulatory

    Takeda Pharmaceuticals (Boston, MA)
    …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
    Takeda Pharmaceuticals (03/13/25)
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  • Global Regulatory Affairs Labeling…

    Chiesi (Cary, NC)
    …and internal guidance documents for related activities and provide training to Regulatory Affairs and other departments and/or affiliates as appropriate. + ... materials and supporting documentation to health authorities. + Support regulatory decisions related to Clinical and Global...authorities as needed in the activities of the Global Regulatory Affairs group. + Provide input to… more
    Chiesi (02/15/25)
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  • Clinical Affairs Manager

    Teleflex (Atlanta, GA)
    Clinical Affairs Manager , Interventional Urology (SouthEast) **Date:** Mar 14, 2025 **Location:** Atlanta, GA, US **Company:** Teleflex **Expected Travel** : ... accuracy or completeness. 1. Roehrborn, Can J Urol 2017 **Position Summary** The Clinical Affairs Manager partners with the commercial organization to… more
    Teleflex (03/15/25)
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  • Senior Manager , Global Regulatory

    Takeda Pharmaceuticals (Boston, MA)
    …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... regulatory activities for assigned marketed product(s) of responsibility. + Provides a regulatory strategic focus on non- clinical and clinical aspects of… more
    Takeda Pharmaceuticals (03/13/25)
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  • Regulatory Affairs CMC…

    Amgen (New Albany, OH)
    The Regulatory Affairs CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products ... Bachelor's degree + 6+ years' experience in manufacturing, testing (QC/QA or clinical ), or distribution in Pharmaceutical/Biotech industry + Regulatory CMC… more
    Amgen (02/23/25)
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  • Senior Regulatory Affairs Specialist

    Grifols Shared Services North America, Inc (Clayton, NC)
    …The purpose of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
    Grifols Shared Services North America, Inc (02/12/25)
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  • Sr. Director, Clinical Affairs

    BD (Becton, Dickinson and Company) (Sparks, MD)
    …corporate standards/procedures, and regulations + Assist in the development and submission of clinical reports to Regulatory Affairs + Provide guidance to ... will have two direct reports (a director, accountable for clinical study managers, and a manager , accountable... Regulatory Affairs associates on clinical strategy issues + Interface with Corporate Medical … more
    BD (Becton, Dickinson and Company) (03/15/25)
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  • Global Regulatory Affairs Quality…

    Chiesi (Cary, NC)
    …looking for_** **Purpose** Ensure adequate compliance and management to the Global Regulatory Affairs quality system according to internal and external ... terms and fit in the GRA overall quality system + Coordinate the Regulatory related cGMP documentation within the electronic document management system. Monitor for… more
    Chiesi (03/08/25)
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