- 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)
- …thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for ... Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the drug… 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 ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- J&J Family of Companies (Raritan, NJ)
- …step of the way. Learn more at https://www.jnj.com/innovative-medicine We are seeking a Director , Global Medical Affairs Strategy & Execution in Oncology. ... Primary Responsibilities include, but are not limited to: The Director , Global Medical Affairs Strategy & Execution collaborates with the Global Medical … more
- Bausch Health (Bridgewater, NJ)
- …it-where your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... approved products (NDA; ANDA; BLA; OTC; Devices; Cosmetic; Nutritional). Manages relevant regulatory strategy components and interactions with Regulatory … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the ... transparent ways of working across the Alliance within US regulatory affairs and will work closely with...for operational matters. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project. Lead and… more
- AbbVie (Branchburg, NJ)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs US Advertising and Promotion is ... responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executes...industry experience. Certification a plus + Experience in US Regulatory Affairs Advertising and Promotion preferred +… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Director , US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the Job** Are you ready to ... you will be considered the resident expert in Global Regulatory Affairs Region NA, Advertising & Promotion...and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- Job Title Director , Clinical Development and Medical Affairs (nitric oxide) Requisition JR000014860 Director , Clinical Development and Medical Affairs ... (Open) Location Bridgewater, NJ Additional Locations Job Description Summary Job Description The Director of Clinical Development and Medical Affairs plays a key… more
- J&J Family of Companies (Raritan, NJ)
- … regulatory strategies are in alignment with product portfolio, regional strategies, CMC- Regulatory Affairs strategy , commercial and market access ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** ...**We are searching for the best talent fo** **r Director , Global Regulatory Leader** **to be in… more
- Sanofi Group (Morristown, NJ)
- …+ Collaborate with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial to align ... **Job title** : Global Medical Director , Evidence Generation - Insights and Strategy...engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs … more
- J&J Family of Companies (Raritan, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... will be responsible for** **:** + Key contributor to regulatory strategy plan, regulatory submission...authority regulated industry + At least 3 years of Regulatory Affairs experience required with focus on… more
- Sanofi Group (Morristown, NJ)
- **Sr. Director , Global Switch Medical Strategy ** + _Location: Morristown, NJ /Hybrid_ **_About the job_** Are you ready to shape the future of Consumer Health? ... + **Cross-Functional Collaboration** - Collaborate with internal stakeholders (R&D, regulatory , safety, medical affairs , commercial) to drive switch-related… more
- Sanofi Group (Morristown, NJ)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global Research ... **Job title** : GRA Device Lead (Associate Director ) **Location:** Cambridge. MA **,** Morristown, NJ **About...accountable to develop and maintain device aspects of project regulatory strategy documents. The incumbent will provide… more
- J&J Family of Companies (Raritan, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... is required. + Relevant experience in the pharmaceutical industry (eg, Regulatory Affairs , Clinical, Medical Information, Pharmacovigilance, etc.) is required.… more
- Bausch Health (Bridgewater, NJ)
- …Nonclinical, Clinical Operations, Clinical/Medical Affairs , Biostatistics, and Regulatory Affairs . + Lead the clinical pharmacology strategy of early and ... it-where your skills and values drive our collective progress and impact. The Director of Clinical Pharmacology will provide expertise and support to internal and… more
- Sanofi Group (Bridgewater, NJ)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug discovery, drug safety, marketing. + ... **Job Title** : Clinical Research Director **Location:** Cambridge, MA **About the Job** Are...the clinical development plan in alignment with the project strategy , its endorsement by governance and its execution in… more
- J&J Family of Companies (Raritan, NJ)
- …legal, quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy , regulatory affairs , data management, medical writing, ... clinical team in responding to medical and compound-related issues + Working with Regulatory Affairs and global clinical operations with regard to responses to… more
- J&J Family of Companies (Raritan, NJ)
- …Hwy 202 **Job Description:** Johnson & Johnson is recruiting for a Sr. Director , Global Commercial Strategy , Bladder Cancer (TAR-210) Global Commercial Lead, ... located in 60 countries around the world. The Sr. Director , Global Commercial Strategy , Bladder Cancer (TAR-210)...analytics, market access, and Health Economics & Pricing, Medical Affairs , Regulatory , Precision Medicine, Data Sciences and… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Product Owner ( Director ) Field NBA **Location:** Morristown NJ or Cambridge MA **About the Job** At Sanofi, we're committed to providing the next-gen ... and solve sooner than ever before. Digital Product Owner ( Director ) Field Next Best Action (NBA) works in a...sales force excellence, customer engagement, R&D, and field medical affairs . In the role of Product Owner Field NBA,… more