- Cytiva (Pensacola, FL)
- …certification requirements and customer expectations.This position reports to the Quality Director Filtration - Membrane Sites and leads both the Quality Control ... Pensacola site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance, and aligning with organizational quality goals.Quality Management… more
- Amgen (Washington, DC)
- …lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead ** **What you will do** Let's do this. Let's ... Director supporting products in Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global...Amgen molecules. In this vital, product-facing role you will lead the Global Regulatory Team… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead , GRAD Oncology. You will ... for complex or highly complex or multiple projects. May lead the Global Regulatory Teams...project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. +… 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
- AbbVie (North Chicago, IL)
- …Tok (https://www.tiktok.com/@abbvie) . 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
- Lilly (San Francisco, CA)
- …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
- Lilly (Indianapolis, IN)
- …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
- Takeda Pharmaceuticals (Boston, MA)
- … Director will lead all submission types. + Accountable for building global regulatory strategies as defined within the GRT and ensure those are ... opportunities. + Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies on product specific… more
- AbbVie (Cambridge, MA)
- …product(s) within Neuroscience and supports the Manager (Senior Manager, Associate Director , Director ( Global Regulatory Lead (GRL)), in the ... + Skill Set: Proven skill at implementing successful US and Canada regulatory strategies, global regulatory experience is a plus. Experience working in a… more
- Citigroup (New York, NY)
- …management position within the Controllers Organization that will report up through the Global Head of Regulatory and Capital Reporting. The individual will ... Provide **thought leadership** to peers and program leaders on US regulatory changes and lead efforts to implement those changes within the reporting framework.… more
- AbbVie (North Chicago, IL)
- …driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL, Director ), in the development & execution of the ... LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , RA Global Regulatory Strategy, US & Canada is responsible for… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible for ... reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types...Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies… more
- Bayer (Whippany, NJ)
- …brilliant and diverse minds to make a real difference, there's only one choice.** ** Director , Global Regulatory Strategist, CGT Combination Products** The ... Director , Global Regulatory Strategist, Cell & Gene Therapy (CGT) Combination Products requires a Global Regulatory Expert who can lead … 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 ... live or their economic status. **POSITION OVERVIEW:** As a Director , Early Oncology Global Regulatory ...and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and ... lead preparation, review, and finalization of CMC documents for global regulatory submissions, including Clinical Trial Applications, Market Authorization… more
- Takeda Pharmaceuticals (Boston, MA)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... empower you to shine? Join us as an Associate Director , Global Regulatory Project Management...**How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co-… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management** - Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be… more
- Ascendis Pharma (Princeton, NJ)
- …team. This is an exciting opportunity to join a rapidly growing innovative company. The Director , Global Regulatory Strategy and Policy Advisor, will be at ... a pivotal role in shaping outcomes that matter. The Director , Global Regulatory Strategy and...Life Science with experience working as an RA project lead of marketing authorization filings, or as a reviewer,… 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
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