- Novo Nordisk (Princeton, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... experience; including hands on related pharmaceutical or medical device/ pharmaceutical combination product experience and actual regulatory experience +… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Sr. Manager , Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations. **In this role, a typical day might include the… more
- System One (Florham Park, NJ)
- …to higher-level management, the Senior Manager focuses on executing regulatory tasks, ensuring compliance , and facilitating cross-functional collaboration to ... Senior Manager , Regulatory Affairs Strategy - Contractor...to QOL initiatives, including variations, renewals, labeling updates, and compliance initiatives. + Collaborate with the regulatory … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …science degree or related field + Minimum of 6+ years experience in the biotech/ pharmaceutical industry with a strong focus in Regulatory Intelligence + Good ... and proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through… more
- Bausch Health (Bridgewater, NJ)
- …monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. Responsibilities **:** + ... strategies and solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies. + Monitors FDA… more
- Sumitomo Pharma (Trenton, NJ)
- …employee encounters is considered confidential. ** Compliance ** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...highly motivated, and experienced individual for the position of Manager , CTSA. The CTSA Associate Manager is… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …network plans for key brand(s) within the Biologics global planning network. The Sr. Manager Bio Network Supply Planning role will master the below key areas to ... projects, non- commercial activities + Develop specific ad hoc analysis, ie regulatory assessments, inventory builds, S&OP visuals, lot tracing. + Provide brand… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... considered for all Medical Affairs programs. Interact with legal and compliance as required. Proactively collaborate with other GxP quality representatives and… more
- Helsinn Therapeutics (US), Inc. (Iselin, NJ)
- … with all appropriate laws and guidelines in all HTU activities. + Supervise the Manager of Compliance Operations. + Serve as an ad-hoc member of the Promotional ... Director of Compliance Compliance Iselin, New Jersey Apply... policies and procedures in accordance with applicable legal, regulatory and industry standards. + Manage annual auditing and… more
- Sumitomo Pharma (Trenton, NJ)
- …employee encounters is considered confidential. ** Compliance ** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...motivated, and experienced individual for the position of **Sr. Manager , Medicaid Contract Administration.** The Sr. Manager ,… more
- Hovione (East Windsor, NJ)
- …of pharmaceutical product development + Possess extensive knowledge of pharmaceutical cGMP and regulatory requirements + Good communication skills (verbal ... as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market. Our people… more
- Sanofi Group (Bridgewater, NJ)
- …systems solutions, market access, business operations, finance, medical affairs, regulatory , legal, compliance , global marketing, training, portfolio marketing, ... **Senior Product Manager , Flu Franchise Marketing** **Location- Bridgewater, NJ** **About...Veeva Promomats. + Ensure all promotional materials adhere to regulatory guidelines and compliance standards. **Promotional Material… more
- Sumitomo Pharma (Trenton, NJ)
- …employee encounters is considered confidential. ** Compliance ** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible… more
- Integra LifeSciences (Princeton, NJ)
- …owners to create quality system documentation and responses in support of regulatory compliance correspondence. The Quality Compliance Technical Writer ... what's possible and making headway to help improve outcomes. The Quality Compliance Technical Writer will work with Quality system leadership and cross functional… more
- Sumitomo Pharma (Trenton, NJ)
- …employee encounters is considered confidential. ** Compliance ** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...motivated, and experienced individual for the position of Sr. Manager , Revenue Accounting. The individual will play a key… more
- Mount Sinai Health System (New York, NY)
- …+ Demonstrated knowledge of clinical research concepts, good clinical practices and regulatory compliance + Proven ability to provide scientific and clinical ... protocols, including federally funded studies, investigator-initiated studies, and/or those from pharmaceutical companies. The manager will instruct and trains… more
- J&J Family of Companies (Somerset, NJ)
- Sr Manager , Commercial Quality - 2406208522W **Description** Johnson & Johnson is recruiting for a Sr Manager Commercial Quality, located in Titusville, NJ, ... Learn more at https://www.jnj.com/. The overall purpose of the Commercial Quality, Senior Manager /QA Associate Director for the US LOC is to ensure high quality… more
- Lundbeck (Manhattan, NY)
- … Environment/ Compliance ** - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to ... Neuroscience Account Manager - Manhattan, NY Requisition ID: 4941 Location:...and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. **REQUIRED EDUCATION, EXPERIENCE and SKILLS:**… more