- Integra LifeSciences (Princeton, NJ)
- …new treatment pathways to advance patient outcomes and set new standards of care. The Director , Global Regulatory Labeling is responsible for overseeing ... affairs and quality assurance and working knowledge of global regulatory labeling requirements in key markets/geographies. + Ability to multi-task… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …pertaining to global and local labeling compliance and quality within Global Regulatory Affairs . + Partners with internal stakeholders and external ... to the best of my knowledge. **Job Description** The Regulatory Affairs - Labeling , Associate Director...CRO partners such as Global Regulatory Compliance, Global Labeling ,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune 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 ...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs provides strategic global regulatory guidance to ... assure timelines and milestones. + With support of Commercial RA , develops initial product labeling and assesses...and guidelines. + Leads as a key member of Global Regulatory Project Teams. + Leads multidisciplinary… more
- Sumitomo Pharma (Trenton, NJ)
- … Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function ... as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Sumitomo Pharma (Trenton, NJ)
- … Regulatory Affairs ** . The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function ... registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). He/she is expected...pharmaceutical industry with minimum of 6 years focused in Regulatory Affairs + Include the qualifications preferred… more
- Bristol Myers Squibb (Princeton, NJ)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... + Ensure global development plans will meet global regulatory requirements by soliciting and integrating...with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...of contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...of contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs… more
- Merck (Rahway, NJ)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... **Summary, Focus and Purpose** The Senior Principal Scientist | Regulatory Affairs Liaison is responsible for development...labeling and obtain shortest time to approval by global regulatory agencies. You will independently manage… more
- Novo Nordisk (Plainsboro, NJ)
- …on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...the Executive Director + Represent NNI Medical Affairs on Global Core Medical Team (CMT)… more
- Bristol Myers Squibb (Princeton, NJ)
- …collaboration with key stakeholders, including US and WW Commercial, Research and Development, Global Drug Development, HEOR, Regulatory Affairs , and other ... their personal lives. Read more: careers.bms.com/working-with-us . **Position: Associate Director , WW Medical Neuropsychiatry Strategy, Schizophrenia** **Location: Princeton Pike… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead will...to the authoring of modules 2.7.3, 2.7.4, 2.5 and labeling for regulatory submissions, contribute the authoring… more
- Integra LifeSciences (Princeton, NJ)
- …brochures and seminars + Monitors product development progress with engineering, manufacturing, regulatory affairs and related departments to ensure product line ... new standards of care. ** Global Senior Product Manager** Reporting to a Senior Director , Global Marketing - Codman Specialty Surgical, CSS, the Global … more
- Integra LifeSciences (Princeton, NJ)
- …brochures and seminars + Monitors product development progress with engineering, manufacturing, regulatory affairs and related departments to ensure product line ... patient outcomes and set new standards of care. Under direct supervision of a Director , Global Marketing - Codman Specialty Surgical, CSS, this role will… more