- Pall (Miami, FL)
- …the Danaher Business System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international ... turn ideas into impact - innovating at the speed of life.As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on… more
- Cepheid (Miami, FL)
- …Union In Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP) ... participating regulatory authorities Provide cross-functional compliance support for global QMS and Intracompany Quality Agreement requirements. Function as SME… more
- Beckman Coulter Diagnostics (Miami, FL)
- …with diagnostic tools that address the world's biggest health challenges. The Global Supplier Quality Engineer - Metals for Beckman Coulter Diagnostics will serve ... to meet quality, delivery and cost objectives.This position is part of the Global Supplier Quality team. The job location for this role is in-person, preferably,… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. **Purpose:** The purpose of the Senior Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) role is ... to develop and implement innovative global regulatory strategies for product(s) in the assigned therapeutic area. The GRL is the accountable decision maker for… more
- Fresenius Medical Center (Waltham, MA)
- …+ ** Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the company's pharmaceutical portfolio, including IND/CTAs, ... strategies, and potential risks to inform decision-making across the organization. + ** Global Regulatory Submissions:** + Oversee the planning, preparation, and… more
- Lilly (Indianapolis, IN)
- …solutions to support communities through philanthropy and volunteerism. **Organization Overview:** Global Regulatory Policy & Strategy strives to enable Lilly ... efficiency in drug development. The purpose of the Associate Vice President - Global Regulatory Affairs, Global Regulatory Policy & Strategy (Genetic… more
- BeOne Medicines (Emeryville, CA)
- **General Description** **_:_** + The Director, Global Regulatory Lead, will be responsible for developing, implementing, and advising on global ... Franchise (Solid Tumors), with a focus on gastrointestinal (GI) indications and a global regulatory remit. **Responsibilities:** + Provides high level global … more
- Takeda Pharmaceuticals (Boston, MA)
- …will inspire you and empower you to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning - GI2 TAU within our ... Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is ... to develop and implement innovative global regulatory strategies for product(s) in the assigned therapeutic area. The GRL is the accountable decision maker for… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **Objective / Purpose:** + Defines, develops and leads global strategies to maximize global regulatory success towards ... leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global … more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director) **Location** : Cambridge, MA or Morristown, ... could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device Head, Specialty Care Device and Combination Products… more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead** **What you will ... Regulatory Affairs Director supporting products in Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership,… 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 is ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for the… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative ... global regulatory strategies and providing strategic regulatory guidance for the global development of various products within the Neuroscience… more
- Otsuka America Pharmaceutical Inc. (Montgomery, AL)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed ... lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides… 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 support… 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 and ... **How you will contribute:** + Defines, develops, and leads global strategies to maximize global regulatory success towards achievement of program objectives… more
- AbbVie (Waltham, MA)
- …(https://www.tiktok.com/@abbvie) . Job Description The Director, Oncology Business Development and Global Regulatory Strategy is responsible for developing and ... approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and manages the scientific and ... to lead preparation, review, and finalization of CMC documents for global regulatory submissions, including Clinical Trial Applications, Market Authorization… more
- Bloomberg (New York, NY)
- … Exam Management and Regulatory Inquiries Officer, you will work with the Global Regulatory Engagement Lead, the Chief Risk Office and Global Compliance ... to regulatory examinations and inquiries and to help develop the global regulatory engagement program to ensure a successful outcome for Bloomberg and its… more
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