- Cytiva (Miami, 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
- Lonza (Madbury, NH)
- Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest ... our daring growth, your expertise will help us technically adhere to regulatory standards and successfully execute innovative processes!The shift schedule for this… 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
- Sanofi Group (Morristown, NJ)
- **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
- 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
- AbbVie (South San Francisco, CA)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory Strategy, ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy… more
- Takeda Pharmaceuticals (Boston, MA)
- …across the portfolio of PDT products. **How you will contribute:** + Serves as the global regulatory lead for one or more projects and and includes ... patients with immunologic, hematologic, and other complex diseases. The Regulatory Lead is accountable for recommending and...leadership of the Global Regulatory … more
- BeiGene (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)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Manager, Global Regulatory Lead Oncology where you will contribute to ... more complex programs. May lead working groups and represents Global Regulatory Team (GRT) at project team meetings. Provides strategic and tactical guidance… more
- BeiGene (San Mateo, CA)
- The Executive Director, Global Regulatory Portfolio Lead will be responsible for developing, implementing, and advising on global regulatory ... Functions of the job:** + Uses extensive knowledge of global regulatory environment and the ability to...+ Preferred candidates will have experience working as a lead in Regulatory Affairs across two or… more
- Novo Nordisk (Lexington, MA)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... on development strategies, and deliver on associated regulatory activities + Lead the Global Regulatory Matrixed Team in defining and executing the … 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
- Bank of America (Charlotte, NC)
- Global Regulatory Reporting Governance & Control Lead Charlotte, North Carolina **Job Description:** At Bank of America, we are guided by a common purpose to ... of Business Job Description:** This role aligns to the Global Regulatory Reporting (GRR) Transformation & Conformance...global Governance & Control function. This individual would lead a team across locations and will work closely… 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products within Regeneron's Genetic Medicine ... role, a typical day might include the following:** + Provide interpretation of regulatory authorities' feedback, policies and guidelines. + Lead the development… more
- Takeda Pharmaceuticals (Boston, MA)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... for assigned programs. **How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co- lead and facilitate product-specific … more
- Takeda Pharmaceuticals (Boston, MA)
- …non-clinical and clinical aspects of drug development and associated regulations. + May serve as global regulatory lead (GRL) on the global project team ... in the global regulatory strategy. + May develop/author or assist Global Regulatory Lead with development of global regulatory strategy. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the… 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
