- 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 ... two clinical development programs as Regulatory Lead (RL), responsible for regulatory strategy and execution activities including IND/CTA, NDA/MAA filing in… 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)
- …growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and plan ... in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred **Travel** Ability… 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
- 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… 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. He/she will...and is responsible for ensuring the execution of regional regulatory strategy in line with the global… 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. He/she will...is expected to lead the development and implementation of regulatory strategy from proof of concept, development,… more
- Sumitomo Pharma (Trenton, NJ)
- …be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy . The job is responsible for developing the ... activities and budget within SMPA and with alliance partners. + Oversee the strategy and development of Medical Affairs plans and scientific platforms. + Ensure… more
- Merck (Rahway, NJ)
- **Job Description** The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory ... point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and...(GRACS) and external to GRACS. + Develops worldwide product regulatory strategy to optimize label and obtain… more
- Sumitomo Pharma (Trenton, NJ)
- …website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The Director , Medical Affairs Strategy (Hematology/Oncology) will be ... a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy . In this role, individuals are responsible for… more
- Sumitomo Pharma (Trenton, NJ)
- …be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy . The job is responsible for strategic direction ... to fight infections. The role will provide set Medical Strategy for both internal company programs and external facing...and external facing HCP and Payer interactions. The Sr. Director of Medical Affairs develops and maintains… 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... regulatory agencies. You will manage the commercial regulatory strategy and execution of such for...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and immune disorders. **Summary:** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi ... strategy . + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and...relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA… 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 ... therapeutic area, across GRA and across the enterprise. + Provide regulatory strategy support to diligence for licensing opportunities as appropriate + Monitor… more
- Bristol Myers Squibb (Princeton, NJ)
- …careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with...with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience… more
- Bayer (Whippany, NJ)
- …and category knowledge to US Medical Strategy , Marketing, New Development, US Regulatory Affairs , Communications, Legal and Global Medical Affairs for ... 832367 **Contact Us** **Email:** hrop_###@bayer.com **Job Segment:** Compliance, Radiology, Regulatory Affairs , Clinical Research, Medical Research, Legal,… more
- AbbVie (Florham Park, NJ)
- …medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions; generation ... input into core brand (product) strategies, and to support medical affairs , marketing activities (promotional material generation and product launches) and market… more
- AbbVie (Florham Park, NJ)
- …Development and Pipeline cross-functional teams and drives the development of medical affairs objectives aligned with strategy . + Reviews, assesses and reports ... and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and… more