- Daiichi Sankyo, Inc. (Bernards, NJ)
- …company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo, Inc. (Bernards, 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...alliance assets for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and… 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)
- …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
- 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
- Bristol Myers Squibb (Madison, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . The Medical Director , US Medical, Multiple Myeloma will report to the Senior Director ... the US Commercialization organization, WW Medical, Clinical Research and Development, Regulatory , Translational Development, and Market Access, and will lead the US… more
- System One (Florham Park, NJ)
- Job Title: Director , US Regulatory Affairs Location: Florham Park, NJ (50% hybrid) Type: contract Overview: Support the Global Therapeutic Area Lead (GTAL), ... Regulatory Affairs (Senior Director ) in...Regulatory Affairs (Senior ...clinical development (as needed) + Contributions to/ finalization of regulatory strategy plans for antimicrobials in development… more
- Bristol Myers Squibb (Madison, NJ)
- …with cross-functional teams to ensure evidence generation efforts support regulatory submissions, reimbursement decisions, and market access strategy . ... . **Position Summary:** We are seeking a dynamic and visionary Worldwide Medical Affairs Disease Area Head (WW-DAH) to oversee our Oncology Worldwide GI, GU Cancers… 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
- 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
- Bristol Myers Squibb (Summit, NJ)
- …are completed + Oversee study centers, countries, investigators and connect with PV, Medical Affairs and Regulatory Affairs + Contribute to develop Quality ... personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director , Therapeutic Area Audit Strategy Lead will be mainly… more
- AbbVie (Florham Park, NJ)
- …clinical development projects. A visible and collaborative role, the Associate Director / Director works in partnership with clinical and regulatory experts to ... own efforts or those of a team. Lead/develop statistical strategy for project development and regulatory submission....Statistical programmers + Data science experts + Global Medical Affairs experts + Regulatory experts *Job title… more
- Bristol Myers Squibb (Madison, NJ)
- …Collaboration : Serve as the primary point of contact for internal (Medical Affairs , Development, Commercial, Regulatory Affairs , Legal, and Compliance) and ... lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Director , Managed Access Programs (MAPs) will be responsible for partnering… 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
