- 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
- 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
- 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
- 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
- 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. (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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator meetings Serve ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global … more
- Insmed Incorporated (Bridgewater, NJ)
- …of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead ) in the pharmaceutical or biotechnology industry or ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Director , Toxicology is a key member of the nonclinical… more
- Merck & Co. (North Wales, PA)
- …in patients who need it most. Invent. Impact. Inspire.Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and ... you to play:-Campaign Development LeadPut marketing strategy into action as you lead the development of our customer experience and campaign planning. Leveraging… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …reporting.Identify trends, innovations and opportunities to ensure adherence to best practices. Lead GCO process improvement initiatives for the global reporting ... 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
- Merck & Co. (Rahway, NJ)
- …the SAP Design Authority team, ensuring effective governance and adherence to best practices. Lead the global teams responsible for delivery and governance of SAP ... and productivity, thereby advancing our Company 's contribution to global medical innovation. Enterprise IT (EIT) is an essential...Team, the EIT SAP Integrated Delivery & Design Authority Lead will assume the crucial role of leading the… more
