- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... globally, coordinating departmental and cross-functional support.Responsibilities Designs and implements regulatory strategies to obtain, maintain product investigative… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in ... each other, and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on… more
- HSBC (New York, NY)
- Director of Wealth, Private Banking and Insurance Regulatory Compliance Brand: HSBC Area of Interest: Risk and Compliance Location: New York, NY, US, ... Group's risk framework. The Director of Wealth, Private Banking and Insurance Regulatory Compliance for US is the management leadership role responsible for… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities: Strategic Leadership and Project ... Job DescriptionJob Summary: The Director , Combination Product Commercialization is a...of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance: Ensure that… more
- Insmed Incorporated (NJ)
- …meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings. Keep abreast of all ... device combination product development at various development stages and product lifecycle management.Stay current with regulatory guidelines and industry… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …capabilities through strategic vendor partnerships. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations. This job ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...management systems and track training completion rates to ensure compliance with safety and regulatory requirements Lead… more
- Novo Nordisk Inc. (Boulder, CO)
- …of technical teams required Experience working to standards required for regulatory compliance of Aseptic Processing facilities required Understanding of ... of both worlds to develop new medicines for patients. The Position The Associate Director of Drug Product Manufacturing is accountable for all clinical drug … more
- Merck & Co. (Rahway, NJ)
- …executive level and build cross-functional partnerships.Solid understanding of security, compliance and regulatory requirements relevant to payments (PCI-DSS) ... Job DescriptionWe are seeking a seasoned IT SAP Finance Director to lead the design, delivery and continuous improvement of SAP Finance solutions across our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Safety/Quality/Training processes, systems, and resources are optimized to support regulatory compliance while enabling scalability, automation, and continuous ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Merck & Co. (Rahway, NJ)
- … development in addition to device development expertise.Strong familiarity with regulatory landscape associated with drug delivery combination product and ... verification testing strategies for innovative combination products?Join our company's Device Product & Process Development (DPPD) Team, which focuses on the design,… more
- BeOne Medicines (Emeryville, CA)
- …primarily in the United States with some activities globally to ensure compliance with applicable regulatory requirements and guidelines, and consistency with ... other regions to ensure global coordination of promotional and non-promotional product communications/activities and ensure compliance with company policies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Sr. Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .Essential Duties and Responsibilities:Program Leadership and Technical ... all activities are conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional and local site… more
- Merck & Co. (Rahway, NJ)
- …Medical Devices, Product Commercialization, Quality Management System Improvement, Regulatory Compliance , Regulatory Inspections, Social Collaboration, ... in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Utilize extensive experience in… more
- Merck & Co. (Rahway, NJ)
- …Recruitment, Process Analytical Technology (PAT), Professional Networking, Raw Materials, Regulatory Compliance , Regulatory Submissions, Release Testing, ... entirety of our non-sterile and sterile clinical portfolio. The Director is responsible for ensuring cGMP compliance ...a state of inspection readiness at all times. The Director should be well engaged with regulatory … more
- Merck & Co. (Rahway, NJ)
- …and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal workflows and performance metrics to ensure departmental KPIs and regulatory compliance are consistently met Implement Medical Review Prospective ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Merck & Co. (Rahway, NJ)
- …lifecycle management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal ... relationships with internal stakeholders, including packaging commercialization, quality, analytical, regulatory , manufacturing, Device Development and Technology, Technical Product… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.-The Packaging Technical Operations organization aims to… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE the Director ... for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.- The Packaging Technical Operations organization aims… more
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