- Novo Nordisk Inc. (Plainsboro, NJ)
- …and maintain local (safety) SOPs. Collaborate with Global Safety on global SOP updates and regulatory changes Physical Requirements 0-10% overnight travel ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...limited to the following: all units in Patient Safety, Global Safety, Medical Information, Field Sales, Customer Complaints Center,… more
- Sanofi Group (Cambridge, MA)
- **Job title: Therapeutic Area Head Global Labeling , Immunology Inflammation and Neurology** + Location: Bridgewater, NJ or Cambridge, MA **About the job** ... Inflammation and Neurology Therapeutic Areas. The position reports to Head of Global Labeling Strategy...Build and maintain relationships with key stake holders in global regulatory affairs, other R&D and commercial… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director, Pipeline Head for Neuroscience, Global Health Economics, Value, and Outcomes Date: May 14, 2024 Location: Parsippany, United States, New Jersey, ... Parsippany, New Jersey** The goals and objectives of the Global Health Economics, Value, and Outcomes department is to...is done in full compliance with Teva's and all regulatory and governance requirements. The Pipeline Head … more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director, Pipeline Head for Immunology, Global Health Economics, Value, and Outcomes Date: May 14, 2024 Location: Parsippany, United States, New Jersey, ... Parsippany, New Jersey** The goals and objectives of the Global Health Economics, Value, and Outcomes department is to...studies, surveys, and economic models. The **Senior Director, Pipeline Head for Immunology** , will develop the TA strategies… more
- Sanofi Group (Bridgewater, NJ)
- …responsible for formulating the Global Regulatory Project Strategy (GRPS), Global Submission Strategy, and core product labeling in development as well ... Regulatory Strategy and Plan, including a global labeling strategy for assigned projects +...and externally as "one GRA voice" with TA, GBU Head and up to the GRA LT when needed… more
- AbbVie (Boston, MA)
- …expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). ... Facebook, Instagram, YouTube and LinkedIn. Job Description The Director, Global Regulatory Lead, is responsible for developing...the direction of a GRS Sr GRL or TA Head . May participate in or lead regulatory … more
- Vanderbilt University Medical Center (Fontana, CA)
- …University Medical Center:** Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community ... position with expertise in protein chemistry, GLP/GMP manufacturing, antibody chemistry/ labeling , and/or HPLC techniques to directly assist with cGMP production… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …to marketed products in US and Canada. In addition, the Senior Director, Commercial Regulatory Affairs, in collaboration with Head , Regulatory Affairs and ... Regulatory Affairs will stay abreast of changes in the global /US/Canadian regulatory framework, analyze proposed legislation/guidance that could impact the… more
- Sanofi Group (Cambridge, MA)
- …RS leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, ... EU and/or global regulatory strategy for assigned projects, including...Groups, Chief Scientific Officer, etc. + Collaborate with the Global Head by providing scientific guidance and… more
- Bausch Health (Bothell, WA)
- …effective aesthetic care options to consumers and physicians alike. The Manager, Regulatory Affairs provides direct support to Solta operations for their globally ... closely with site Quality, R&D, Operations, and regional peers to support global licensing and registrations, and to ensure the effective execution and management… more
- J&J Family of Companies (Skillman, NJ)
- …for: ** Global Risk Assessment & Safety Physician** This position reports to the Head of the Global Safety Risk Assessment Team and is based in Skillman, ... more information, click here (https://www.youtube.com/watch?v=XhsbOsBiX\_M) . **Role reports to:** Head of Global Safety Risk Assessment **Location:** Kenvue's… more
- Merck (West Point, PA)
- **Job Description** Global Clinical Supply Operations is seeking a highly motivated individual to serve as a team lead in label operations. The team lead will be ... The successful candidate should have a working knowledge of clinical labeling , packaging and/or operations planning, including the understanding that all clinical… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Development, Proof of Clinical Principle, Release of Full Development, input into regulatory strategies and labeling discussions). + Provides medical guidance ... and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering… more
- Church & Dwight Co., Inc. (Fort Collins, CO)
- …This role has the responsibility to ensure all Waterpik products, packaging, and labeling are compliant for domestic and global market access. Specifically, this ... manage and lead the Product Compliance team, monitor the global compliance and regulatory landscape, and ultimately...Physical Requirements + Reporting Relationship: Reports directly to the Head of Global New Products Engineering +… more
- Merck (West Point, PA)
- **Job Description** Global Clinical Supply Operations is seeking a highly motivated individual to serve as a team lead in Print Technician Team. The team lead will ... The successful candidate should have a working knowledge of clinical labeling , packaging and/or operations planning, including the understanding that all clinical… more
- Ensign-Bickford Aerospace and Defense (Graham, KY)
- …located within our Ensign-Bickford Aerospace & Defense Company business, a global leader of mission-critical hardware and systems solutions including precision ... Health & Environmental Manager at its Graham, Kentucky facility. + Complete Regulatory compliance including training, and all misc. documentation. + Supports Process… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …Good Documentation Practices would be ideal. + Knowledge of quality and regulatory requirements important to pharmaceutical manufacturing labs would be ideal. + ... controlled environment requiring special gowning and wear protective clothing over the head , face, hands, feet and body. This may include additional hearing… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …progress toward achieving development goals. + General knowledge with cGMP manufacturing, regulatory regulations is preferred. **What you bring to Takeda:** + High ... controlled environment requiring special gowning and wear protective clothing over the head , face, hands, feet and body. This may include additional hearing… more