- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …gathering that also accounts for nuances between different world regions and addresses regional regulatory needs and priorities (eg through collaboration with ... for collecting, analyzing, synthesizing and communicating intelligence relating to the US regulatory framework. Regulatory PolicyScans the horizon… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …JD) preferred. Experience Qualifications:4 or More Years of proven experience in a regional regulatory lead role7 or More Years of relevant pharmaceutical ... and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Daiichi Sankyo, and where applicable, partner companies for the development and approval of US , EU and global CCDS documents for regulatory filings and HA ... More Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including CCDS and US /EU labeling experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... within CSPV function. Improve QA engagement with CSPV at the global, regional , and local level pertinent to metrics, lessons learned and improved processes.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, ... Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experienceExperience with ex-… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education...development, CMR is involved. The one thing that keeps us all marching to the same beat is our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …programs to support the business functions of Daiichi Sankyo (DS) in the US , EU, Japan, and other global sites. These business functions include: Clinical ... Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Clinical Trial Information Disclosure Manager leads company operational activities to comply with US , EU, Japan and other regional disclosure regulations and the ... company initiatives, strategies and operational activities to comply with the US , EU, Japan and other regional trial disclosure regulations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …be part of the Compliance organization and will report directly to the Director , Compliance Training, Policy & Communications. This position will be responsible for ... business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal).ResponsibilitiesTraining… more
- Insmed Incorporated (Bridgewater, NJ)
- …to-be-marketed productsResponsibilitiesIn close collaboration with Regulatory project leads in the US , EU, and Japan, the Director , Regulatory Labeling ... 2023, we became Great Place to Work-certified in the US for the third year in a row. We...Workplaces for Millennials™ lists.OverviewThis is a key role providing regulatory expertise and guidance to internal stakeholders for successful… more
- Insmed Incorporated (Bridgewater, NJ)
- …and our employees agree. In July 2023, we became Great Place to Work-certified in the US for the third year in a row. We are also honored to have been listed ... New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality Operations will… more
- Insmed Incorporated (Bridgewater, NJ)
- …and our employees agree. In July 2023, we became Great Place to Work-certified in the US for the third year in a row. We are also honored to have been listed ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing will be a key member of the Brand team for… more
- Lennar Homes (Cherry Hill, NJ)
- … regional and division level management. Communicate and interpret information from regulatory reports and technical data with Regional President, Regional ... of diversity within our workforce to drive innovation & sustainable growth. Regional Environmental Manager: Lennar is seeking a Regional Environmental Manager… more
- S&P Global (New York, NY)
- …law. BSMGMT202.2 - Middle Professional Tier II (EEO Job Group) **Job ID:** 298786 **Posted On:** 2024-04-30 **Location:** New York, New York, United States ... to contracted standards. **Compensation/Benefits Information (This section is only applicable to US candidates):** S&P Global states that the anticipated base… more
- Pfizer (New York, NY)
- …with Health Authorities in relation to the assigned project(s). Role may be combined with other Regulatory Role (ie regional US or EU regulatory role ... Director , Lead and coordinate a virtual global regulatory strategy team (GRST), encompassing regional ...an E-Verify employer. This position requires permanent work authorization in the United States . Regulatory … more
- Bristol Myers Squibb (Trenton, NJ)
- …goals, both at work and in their personal lives. Read more: careers.bms.com/working-with- us . **Associate Director , Clinical Nurse Consultant** _The Clinical ... Nurse Consultant (CNC) Associate Director is the leader of a US ...of integrity and dependability + Current working knowledge of US legal, regulatory , and compliance regulations and… more
- Ascendis Pharma (Princeton, NJ)
- …activities across programs and stages of development, with specific responsibility for the United States and the Americas and supporting global needs as ... The Regulatory Affairs (RA) Associate Director , Labeling...Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for… more
- Cardinal Health (Trenton, NJ)
- …to more than 200 inpatient facilities and retail pharmacies across the United States . The Regional Director has 3 Direct Reports and approximately 90 ... Solutions provides a highly comprehensive, universal solution for hospital pharmacies. The Regional Director of Pharmacy oversees the Remote Pharmacy Services… more
