- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary:** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA… 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...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …. Brings issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach ... issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned...resolution. + Participate in global product team meetings to provide US … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical ... or other special projects. May initiate and/or contribute to global process improvements. + Provides regulatory guidance...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus ... on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or More Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ 7 or More Years in the pharmaceutical industry + 4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA **Travel** Ability to travel up to ... preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others (team members); meet… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to 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)
- …centered around rare diseases and immune disorders. **Summary** This 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
- Pfizer (Peapack, NJ)
- …Quality and compliance. + 5-7 years minimum experience focusing on Pharmacovigilance, Regulatory Affairs or within a Health Authority. + Extensive knowledge ... providing direction and strategy for all inspections involving WMS deliverables. As the Director of Quality Management, you will lead global inspection readiness… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, Accounting/Finance, Global ... to and responsible for the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. **How you'll spend your day** The Director ,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **Summary** This 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
- Sanofi Group (Morristown, NJ)
- **Job Title:** US Medical Director - Portfolio, New Products, Innovation- Vaccines **Location** : Bridgewater, NJ **About the Job:** The North American Medical Team ... our team and mirrors the healthcare communities we engage. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** US Medical Director , Mainline Vaccines **Location** : Bridgewater, NJ / Morristown, NJ **About the Job** The North American Medical Team at Sanofi is ... our team and mirrors the healthcare communities we engage. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …excellence across the organization, building productive cross-function connections (eg, Global , Marketing, Medical Affairs , etc.,) to enhance organizational ... Associate Director Launch Excellence Date: Dec 23, 2024 Location:...**Cross-Functional Leadership** : Lead cross-functional teams, including marketing, sales, regulatory , and medical affairs , to ensure a… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs . Facilitate operational meetings with CROs, License ... tracks regulatory trends, legislative changes, and guidelines issued by global regulatory agencies (FDA, EMA, MHRA, etc.) related to CSPV. Participates in… more
- Sanofi Group (Morristown, NJ)
- …to work effectively with cross-functional groups which may include, HCP marketing, Global Marketing, Sales, Research & Development, Medical Affairs , Business ... **Job Title:** Associate Director , Consumer Marketing - US Rare Hematology **Location**...Consumer marketing for rare hematology. We are an innovative global healthcare company, committed to transforming the lives of… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and new people to make a difference with. **The opportunity** The Senior Director , Associate General Counsel, Market Access and Pricing role reports directly to the ... US, as well as providing legal support to Government Affairs and Payor Marketing. This role partners principally with...lobbying strategy; and engaging, as needed, with government and regulatory agencies to educate on the implications of specific… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. We are currently seeking a Global Oncology Medical Affairs (GOMA) Publications Intern for summer 2025. This ... per week. **Responsibilities: ** Daiichi Sankyo Inc's Oncology Publications team within Global Oncology Medical Affairs (GOMA) is seeking a Publications Systems… more