- 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
- 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)
- …to ensure registration strategies adhere to therapeutic area direction and corporate objectives. Serve as Global Regulatory Lead or US regulatory lead ... preparation, alignment and formulation of strategy for US and/or global regulatory submissions. This position ensures ...or global representation on project teams; may lead regulatory teams for more complex projects.… 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
- Merck & Co. (Rahway, NJ)
- …supporting the Disease Area Strategies for Melanoma.Reporting to the Global Disease Lead for Skin Cancers, The Director of Global Oncology Marketing ... engagement execution, target product profile development, health authority interactions, global regulatory filing strategy, organized customer interactions, and… 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
- Catalent (Manassas, VA)
- … Regulatory Affairs and regulatory compliance. Will prepare for and lead regulatory meetings, designing regulatory compliance strategy to ensure ... Associate Director , Regulatory Affairs Position Summary: Catalent is a global , high-growth, public company, and a leading partner for the pharmaceutical… 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
- 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 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)
- …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)
- …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)
- …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
- Merck & Co. (North Wales, PA)
- …help people with cancer across the globe.This individual serves as the: Associate Director , US Oncology Campaign Development Lead (CDL) - OCAR This individual ... structures to overcome obstacles.Vast experience in the end-to-end commercial, regulatory , and legal compliance policies, review, and delivery processAgency/vendor… 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 and collecting… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development. ... product programs under your leadership.Remain current in relevant worldwide regulatory guidance and standards. Lead /support/oversee clinical supplies production… 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)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization ... medications when needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and… more
