- Cytiva (Pensacola, FL)
- …site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance, and aligning with organizational quality goals.Quality Management ... continuous improvement.Strategic Partnership & Advocacy: Collaborate with site and global leadership to address process changes, advocate for site-specific needs,… more
- Lilly (San Francisco, CA)
- …**Purpose:** The purpose of the Senior Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative ... drive acceleration strategies. Identify and effectively communicate regulatory risks. + Lead Global Regulatory Team in the development of regulatory … more
- Amgen (Washington, DC)
- …the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead ** **What you will do** Let's do this. Let's ... management of all Amgen molecules. In this vital, product-facing role you will lead the Global Regulatory Team (GRT) in the Regulatory Affairs… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead , GRAD Oncology. You will provide strategic ... be responsible for complex or highly complex or multiple projects. May lead the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as… more
- Lilly (Indianapolis, IN)
- …**Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative ... acceleration strategies. Identify and effectively communicate regulatory risks. + Lead Global Regulatory Team in the development of RSD(s) for assigned… more
- Takeda Pharmaceuticals (Boston, MA)
- … strategy and coordinating life cycle activities across the portfolio of PDT products. The Global Regulatory Lead , Director, in PDT R&D: + Serves as the ... global regulatory lead for one or more projects and and includes leadership of the Global Regulatory Team (GRT) composed of core regulatory … more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Regulatory Lead **Location** : Bridgewater, NJ / Morristown, NJ/ Cambridge, MA (hybrid) **About the Job:** Are you ready to shape the ... accelerate progress. Join our Immunology & Inflammation Regulatory Team as Global Regulatory Lead and you'll be responsible for the development &… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Regulatory Lead **Location** : Morristown, NJ, Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for… more
- BeOne Medicines (Emeryville, CA)
- **General Description** **_:_** + The Director, Global Regulatory Lead , will be responsible for developing, implementing, and advising on global ... on Health Authority interactions. + Uses extensive knowledge of global regulatory requirements and the ability to...a global strategy and can develop and lead execution of holistic regulatory strategy while… more
- Takeda Pharmaceuticals (Boston, MA)
- …therapies for patients with immunologic, hematologic, and other complex diseases. The Global Regulatory Device Labeling Strategy Lead (Senior Manager) ... pharmaceutical drug and device. + Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub team to ensure… more
- Takeda Pharmaceuticals (Boston, MA)
- …The Director will lead all submission types. + Accountable for building global regulatory strategies as defined within the GRT and ensure those are ... Description** **Objective / Purpose:** + Defines, develops and leads global strategies to maximize global regulatory...Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the role is primarily focused on early oncology assets, you may act as the Global Regulatory Lead for early-stage, late-stage, or other programs depending on ... Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams and… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global ... submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains … more
- Takeda Pharmaceuticals (Boston, MA)
- … Global Regulatory Affairs, Marketed Products with the following duties: Assist the Global Regulatory Lead (GRL) and is accountable for working with ... and executed, ensuring global regulatory compliance; Assist the Global Regulatory Lead with Health Authority meetings and responses; Partner with… more
- Gilead Sciences, Inc. (Foster City, CA)
- … strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will ... Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides… more
- Gilead Sciences, Inc. (Foster City, CA)
- … strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will ... Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- … regulatory guidance and perspective to the cross-functional team in conjunction with global regulatory lead (s). + Prepare, coordinate and/or review all ... teams, to ensure Otsuka's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary regions/markets of… more
- AbbVie (Irvine, CA)
- …coordination, management of global submissions to support new registrations. As Global regulatory lead (GRL), directs and supports development of ... policy, intelligence interpretation and strategy for medical devices to support global regulatory plans, due diligence, integration, and divestitures. + Acts… more
- AbbVie (North Chicago, IL)
- …products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL, Director), in the development & ... Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director, RA Global Regulatory Strategy, US & Canada is responsible for the development… more
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