- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy Princeton, NJ, USA Req #415 Wednesday, November 27, 2024 Looking for a chance to make a meaningful difference ... in US and Europe. Position Summary: + Under the direction of regulatory affairs management, the incumbent independently prepares and directs global … more
- Ascendis Pharma (Princeton, NJ)
- …committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will be an ... promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and..., Advertising and Promotion is responsible for providing commercial regulatory strategy and leadership to enable the US… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary:** The Associate Director , Regulatory Affairs - Regulatory Project ... (RPM) provides planning and drives coordination of global and US regulatory activities. The Associate Director...provides impactful contributions to the RPM group and the regulatory affairs organization by identifying gaps in… more
- Sumitomo Pharma (Trenton, NJ)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs ** . The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US ....I-IV Research & Development Activities** + As a Regional Regulatory Lead, manage regional ( United States… more
- Sumitomo Pharma (Trenton, NJ)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US ....I-IV Research & Development Activities + As a Regional Regulatory Lead, manage regional ( United States… more
- J&J Family of Companies (Raritan, NJ)
- Johnson & Johnson is currently seeking a Senior Director , Regulatory Affairs Global Strategy Implementation to join our team preferably located in Raritan, ... health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are...At Johnson & Johnson, we all belong. The Senior Director , Regulatory Affairs Global Strategy… 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...you if:** + If you bring strong understanding of US FDA and international pharmaceutical guidance, regulations, drug development… more
- NJEDA (Trenton, NJ)
- …New Jersey's future with innovative economic development at NJEDA. Job Overview + The Director of Legislative and Regulatory Affairs works to support the ... The Director will report to the Managing Director of Legislative and Regulatory Affairs...Selected candidates must be authorized to work in the United States per the Department of Homeland… more
- Bristol Myers Squibb (Princeton, NJ)
- …BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in ... **Working with Us ** Challenging. Meaningful. Life-changing. Those aren't words that... . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Merck (Rahway, NJ)
- **Job Description** The Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory ... maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The...in certain states and cities within the United States . Final determinations with respect to… 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)
- …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… 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA submission experience + ... and immune disorders. **Summary:** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … 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
- Amneal Pharmaceuticals (Piscataway, NJ)
- Description: The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical/ FDA Communications.Assists the Senior ... Director of Regulatory Affairs / Clinical Affairs in...Audits conducted by the CRA ANDA Department within the US and International. + Submission/tracking of inter department communications… more
- City of New York (New York, NY)
- …Mayor's Office of Community Mental Health (OCMH) is seeking a Deputy Executive Director , External Affairs who will head the multidisciplinary External Affairs ... Director of OCMH and will directly manage 4 staff members.The Deputy Executive Director , External Affairs will work closely with the Executive Director … more
- Sumitomo Pharma (Trenton, NJ)
- …us .sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The Director , Medical Affairs Strategy (Hematology/Oncology) will be a key member of ... company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada,...the Medical Affairs team reporting to the Executive Director ,… more