- Pall (Miami, FL)
- …the Danaher Business System which makes everything possible. Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets ... impact - innovating at the speed of life.As a global leader in high-tech filtration, separation, and purification, Pall...or material science fields with 15 years of progressive Regulatory compliance and / or quality assurance… more
- Beckman Coulter Diagnostics (Miami, FL)
- …that working for Beckman Coulter Diagnostics can provide.This position reports to the Sr. Director of Global Supplier Quality responsible for global ... lives with diagnostic tools that address the world's biggest health challenges. The Global Supplier Quality Engineer - Metals for Beckman Coulter Diagnostics… more
- Danaher Corporation (Port Washington, NY)
- …System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. Director Global Quality and Regulatory Compliance ... - innovating at the speed of life. As a global leader in high-tech filtration, separation, and purification, Pall...or material science fields with 15 years of progressive Regulatory compliance and / or quality assurance… more
- Amgen (Washington, DC)
- …and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead** **What you will do** Let's ... Director supporting products in Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global...the position. As an organization dedicated to improving the quality of life for people around the world, Amgen… 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 ... to stakeholders in development, manufacturing, and quality + Ensures that global CMC regulatory commitments are defined based on approved submissions for… more
- Lundbeck (Deerfield, IL)
- Director US Regulatory Global Strategic Labelling - Remote Opportunity Requisition ID: 6420 Location: Deerfield, IL, US Do you want to join a team where the ... - open to candidates anywhere in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling will lead… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director ) **Location** : Cambridge, MA or ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device Head, Specialty Care Device and Combination… 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...cross-functional sub teams and working groups. + Creates high quality , complaint regulatory documents (eg, BLAs, INDs,… more
- Lilly (Indianapolis, IN)
- …to make 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… more
- Lilly (Indianapolis, IN)
- …them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC ... CMC regulatory strategies in collaboration with other regulatory , manufacturing, quality and project personnel to... regulatory strategy and update strategy based upon global regulatory changes. + Provide regulatory… more
- AbbVie (Irvine, CA)
- …coordination, management of global submissions to support new registrations. As Global regulatory lead (GRL), directs and supports development of the ... policy, intelligence interpretation and strategy for medical devices to support global regulatory plans, due diligence, integration, and divestitures. + Acts… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …and tools to promote engaged, collaborative, and results-driven work environments. The Director , Global Programs ( Regulatory and Laboratory) has the ... leadership team, is responsible for developing and implementing a global growth strategy for USP's externally funded regulatory...standards, you will play a vital role in increasing global access to high- quality medicines through public… more
- Fresenius Medical Center (Waltham, MA)
- …and industry groups. + Provide leadership in managing global regulatory submissions, ensuring efficient and high- quality execution. + **Market Access ... + ** Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the company's pharmaceutical portfolio, including IND/CTAs,… more
- Bausch Health (Bridgewater, NJ)
- …creates itwhere your skills and values drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for ... labeling strategy, to deliver high quality submission labeling and artwork for complex drug products,...documents for new products. + Solid understanding of pharmaceutical regulatory affairs, global labeling regulatory … more
- Herbalife (Torrance, CA)
- Director , Global Regulatory Affairs - Corporate Category: Legal Position Type: Regular Full-Time External ID: 14913 Location: Torrance, CA, United States ... Now **Overview** **THE ROLE:** Reporting to the VP of Global Regulatory & Post-market Safety Affairs, this...+ Ability to successfully chip in to improving the quality of internal regulatory policies, processes, programs… more
- Edgewell Personal Care (Allendale, NJ)
- …Edgewell's values and behaviors. **Accountabilities** + Responsible for leading Edgewell's Global Regulatory organization. + Demonstrate strong business acumen, ... knowledge of Canadian Registration Processes and NAFTA is desired. + Knowledge of global regulatory framework for consumer safety and pharmacovigilance. + Proven… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... regulatory individuals to ensure timely delivery of high quality of regulatory dossiers and strategies according...regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and… 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 lead ... Represents Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams.… 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 lead ... Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory...+ BA/BS with 10+ years' relevant experience. + Significant regulatory , quality , compliance or related experience in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may... Labeling Operations and Compliance Leads to produce high quality labeling documentation. + Establishes Processes and Best Practices:… more
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