- 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...pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience… 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 ... RA strategy into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance bodies.Serve as a… more
- Merck & Co. (Rahway, NJ)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is... regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... 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)
- …pharmaceutical, life sciences and/or healthcare space Understanding and experience with global regulatory requirements for Medical Device and/or AI algorithms ... diagnostics and pharma? Then you could be our new Global Marketing Director of Digital Diagnostics! -...stakeholders across HH, our Research & Development Division, Medical Affairs , Regulatory , Legal etc. as well as… 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 ... around rare diseases and immune disorders.Summary With the Head of Government Affairs & Public Policy, this position will help lead Daiichi Sankyo's engagement… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategies, activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, ... is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through...preferred Experience Qualifications7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years… more
- Merck & Co. (Rahway, NJ)
- …communications with staff, colleagues across CMC development, Quality Assurance, and CMC Regulatory Affairs as needed to ensure understanding of needs, proper ... Job DescriptionThe Executive Director of Materials and Biophysical Characterization is responsible for providing strategic and technical leadership for materials… 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 ... of Dossier Planning will report to Head of Global Regulatory Operations and be an active...and Regulatory operations required.4 or More Years regulatory affairs including filing NDA and sNDA.… more
- Merck & Co. (Rahway, NJ)
- …regulatory requirements- Serving as regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of labeling ... and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance...Labeling Therapeutic Area, and under the supervision of the Global Labeling Strategic Director , the GLL is… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the ... leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… 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 ... rare diseases and immune disorders. Summary Oversees early-stage trials, such as global clinical development program for multiple product candidates with one or more… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global ... and compliance related areas. Oversight Provide strategic direction pertinent to CSPV Medical Affairs activities for internal QA team ( global / local), and not… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations through internal technical ... significant experience in scientific/ regulatory fields required- Experience in international Regulatory Affairs - CMC preferred Daiichi Sankyo, Inc. is an… 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 ... areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities related...and is also an integral member of the Medical Affairs Team. This position plays a key role in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... as Pharm Tech SC and biologics, Corporate Business Management)Partner and collaborate with global marketing, global medical affairs , global payers… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety ... and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services Project Management and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Liasions to ensure successful implementation of CDx and data collection- Supports Regulatory affairs in providing content and providing review of documents ... for cardiovascular diseases, 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)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etcQualifications: Successful candidates will be able ... new medicines to help peopleUnder the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
