- Novo Nordisk Inc. (Plainsboro, NJ)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... advise on development strategies, and deliver on associated regulatory activities Lead the Global Regulatory Matrixed Team in defining and executing the … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...or More Years of proven experience in a regional regulatory lead role7 or More Years of… more
- Merck & Co. (Rahway, NJ)
- …review and final approval of all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and ... to Executive Director or Associate Vice President, Therapeutic Area Lead .Develops worldwide product regulatory strategy to optimize label and obtain… more
- Merck & Co. (Rockville, MD)
- …product and regulatory policy matters under the supervision of the Executive Director , US Lead , US Regulatory Policy.Participating in industry and ... Job DescriptionThe Global Regulatory Policy & Intelligence (GRPI)...to support the company's enterprise policy agenda.Responsibilities of the Director , US Regulatory Policy, will include:Proactively monitoring… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Policy activities focused on the USA, alongside coordinating the global team.Responsibilities Lead and manage a global regulatory intelligence and policy ... is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through...of leading Regulatory Intelligence, this role will lead the development and implementation of a global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier ... Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited... of Dossier Planning will report to Head of Global Regulatory Operations and be an active… 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 ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...quality metrics and share with study team, Operations Program Lead , and Sr. Director for the compound,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 Regulatory Leads (GRLs). This position may...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionCompanion Animal Global Marketing - Director , Parasiticide Portfolio MarketingThe Companion Animal (CA) Business unit leads strategy development ... respective categories in the Companion Animal Health market.In this new position, the Director , Parasiticide portfolio Marketing will lead the brand and product… more
- Merck & Co. (Rahway, NJ)
- …commercialization, including product development team, target product profile development, global regulatory filing strategy, launch readiness reviews, organized ... Job DescriptionWe have an exciting Director opportunity to join our global ...alliance partner and internal cross functional team membersSupport the Global Asset Lead to develop the Integrated… more
- Merck & Co. (Rahway, NJ)
- …Development Associate Principal Scientist - Device Engineering and Early Development Lead (Associate Director Equivalent)Our company's Device Development (DD) ... the drug delivery and combination produce space to:Drive pipeline development. Lead the core engineering technical device development team(s) supporting individual… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Global Oncology Communications The role of Director , Global Communications, Oncology is a unique opportunity to join our Company, a ... for this role will work under the guidance of the Executive Director , Global Oncology Communications in a fast-paced and ever-changing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, ... device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key...RA Policy and Intelligence: Keep abreast of the changing global regulatory environment for devices and share/educate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary The purpose of this position is to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry ... set the outsourcing strategy for the regulated bioanalytical sciences and will lead regulatory interactions related to bioanalysis and evaluates/sets the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...project teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead .Responsibilities:Medical Monitoring Planning (MD Only): For ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … education, and process development projects, as required. May serve on or lead global initiatives (eg, process improvement, Protocol review, training, SOP ... disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global...multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... as other research areas centered around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy closely aligned with the business… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing… more
