- 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...you if:** + If you bring strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development… 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 ... 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …leader will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA ... accountable for ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... growth, thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan… 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)
- …More Years pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + ... US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI,… 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 developing and executing regulatory strategies for antimicrobial/ antifungal programs globally or within… more
- Merck (Rahway, NJ)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... advance our pipeline and drive our strategic priorities. The Director , Principal Scientist | Regulatory Affairs...in certain states and cities within the United States . Final determinations with respect to… more
- Merck (Rahway, NJ)
- …Development Execution, The primary function includes coordinating various GRACS (Global Regulatory Affairs and Clinical Safety) functional areas, to ensure ... implementation and maintenance of regulatory activities associated with assigned Company Business Development (BD)...in certain states and cities within the United States . Final determinations with respect to… more
- Bristol Myers Squibb (Madison, NJ)
- …pursue their goals, both at work 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 , US Medical Multiple Myeloma Lead. He/she...Responsibilities** + Strategic and Tactical Planning: Responsible for the US Medical Affairs plans, in coordination with… more
- Bristol Myers Squibb (Madison, NJ)
- **Working with Us ** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is ... at work and in their personal lives. Read more: careers.bms.com/working-with- us . **Position Summary:** We are seeking a dynamic...We are seeking a dynamic and visionary Worldwide Medical Affairs Disease Area Head (WW-DAH) to oversee our Oncology… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …to the terms and conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer, Gilead Sciences Inc. is committed ... be part of a team of Medical Scientists reporting to a Field Director . The MS will disseminate clinical information about Gilead's innovative hematology and oncology… more
- Veterans Affairs, Veterans Health Administration (Lyons, NJ)
- …professional nurse in a State, Territory or Commonwealth (ie, Puerto Rico) of the United States , or the District of Columbia. Graduate Nurse Technician (GNT) ... Director . Maintains knowledge and ensures compliance with all regulatory and accreditation standards, directives, policies, and standard operating procedures… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …with significant unmet medical needs in North American markets. In the United States , MTPA launched rare disease treatments including RADICAVA(R) (edaravone) ... with other internal partners, eg: Biostatistics, Clinical Operations, Safety, Quality Assurance, Regulatory Affairs and external partners, eg: CROs, to ensure… 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 **Location:**...engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs … more
- Merck (Rahway, NJ)
- …with key stakeholders, including research and development, manufacturing, quality assurance, regulatory affairs , and external partners, to ensure alignment and ... **Job Description** The Executive Director , Device Technical Operations is a pivotal leadership...in certain states and cities within the United States . Final determinations with respect to… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …with significant unmet medical needs in North American markets. In the United States , MTPA launched rare disease treatments including RADICAVA(R) (edaravone) ... Rooted in Tradition** . Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a US subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a… more
- Merck (Rahway, NJ)
- …staff, Pharmaceutical Development colleagues, Quality Assurance, Technical Operations, and CMC Regulatory Affairs as needed to ensure understanding of needs, ... **Job Description** The Executive Director for Cell Based Sciences within Analytical R&D...in certain states and cities within the United States . Final determinations with respect to… more
- Sanofi Group (Morristown, NJ)
- …scientific exchange and engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop and launch ... **Job title** **_:_** Global Medical Senior Director Dermatology and Rheumatology, Pipeline Indications **Location:** Cambridge,...Care Immunology team is rapidly expanding. Specialty Care Medical Affairs have a vision to be the leaders in… more
- Teva Pharmaceuticals (Parsippany, NJ)
- … Director , Patent - Parsippany, NJ Date: Feb 26, 2025 Location: Parsippany, United States , New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 60468 **Who ... implementing IP strategies for our generic products in the US market. Reporting to the Senior Director ,..., Patent, you'll collaborate with cross-functional teams, including R&D, regulatory affairs , and portfolio management, to ensure… more