- Leica Biosystems (Boston, MA)
- …oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in support of CDx trials and ... agencies on new product development and strategic initiatives to lead the regulatory activities for global commercialization. This position reports to… more
- Cepheid (Miami, FL)
- …of our team, you'll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission ... about the Danaher Business System which makes everything possible.The Regulatory Affairs Principal is responsible for serving as RA... Affairs Principal is responsible for serving as RA lead on New Product Development (NPD) core teams, working… more
- Beckman Coulter Diagnostics (Chaska, MN)
- …with diagnostic tools that address the world's biggest health challenges. The Global Supplier Quality Engineer - Metals for Beckman Coulter Diagnostics will serve ... Operational SQE's and our Sourcing Commodity Managers, you will lead efforts to develop long-term supplier partnerships to elevate...delivery and cost objectives.This position is part of the Global Supplier Quality team. The job location for this… more
- Cytiva (Miami, FL)
- …the implementation of Filtration Product Lifecycle Process in Cytiva global systemDevelop standard documentation practices aligned across all filtration ... claims, specifications and their evidence are maintained and align with regulatory and customer's requirementsLead filtration product engineering teams training on … 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)
- …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
- 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
- Sanofi Group (Morristown, NJ)
- **Job title:** Global Regulatory Lead **Location:** Cambridge, MA , Morristown, NJ **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 Lead (GRL) is the fully accountable decision maker for the… more
- BeOne Medicines (Emeryville, CA)
- **General Description** **_:_** + The Director, Global Regulatory Lead , will be responsible for developing, implementing, and advising on global ... with a focus on gastrointestinal (GI) indications and a global regulatory remit. **Responsibilities:** + Provides high...a global strategy and can develop and lead execution of holistic regulatory strategy while… 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
- Takeda Pharmaceuticals (Boston, MA)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... providing operational support for assigned programs. + Partnering with the program Global Regulatory Lead (GRL), co- lead and facilitate product-specific … more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- …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
- Gilead Sciences, Inc. (Parsippany, NJ)
- … 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. (Parsippany, NJ)
- … 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
- AbbVie (San Francisco, CA)
- …with multiple driver indications within a Therapeutic Area and supports the Manager ( Global Regulatory Lead (GRL), Associate Director, or Director), in ... Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager, RA Global Regulatory Strategy, US & Canada position is responsible for the… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … 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 ... support and execute remediation of critical gaps in regulatory reporting and bolster the team's ability to meet regulatory commitments to various constituencies… more
- Sanofi Group (Morristown, NJ)
- …this innovative therapeutic platform. The position is within the mRNA Therapeutic Area, reporting to Global Regulatory Lead . As a key member of the Global ... world. **Main Responsibilities** + The Regulatory Strategist (RS) enables the Global Regulatory Lead (GRL) providing quality regulatory input and… more
- Teva Pharmaceuticals (West Chester, PA)
- …day** * Responsible to manage Product Submission Team and dossier timelines. * Accountable to Global Regulatory Lead and Global Regulatory Affairs, ... Innovative Medicine Dossier Project Manager, a key member of Global Regulatory Affairs, will be responsible to...adaptations needed as challenges arise. * In collaboration with regulatory lead and project leader, conduct scenario… more
- Rhythm Pharmaceuticals (Boston, MA)
- … Global Regulatory Affairs. Responsibilities and Duties + Act as the Global Regulatory Lead on multi-disciplinary project teams and provide strategic ... strategies for the program(s) under your accountability. You will lead the regulatory strategy and initiatives for...execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will… more
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