- 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
- Insight Global (Basking Ridge, NJ)
- …Time Zone is preferred but not required. Responsibilities: Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA ... 10+ years in the pharmaceutical industry. 8+ years in regulatory affairs . Experience in providing regulatory...processes. In depth knowledge of oncology and associated RA strategy Experience acting as primary point of contact with… 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
- 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
- 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)
- …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
- Novo Nordisk (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential… 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
- 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
- Merck (North Wales, PA)
- …the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launch + Understanding of the ... **Job Description** Reports to the Director /Senior Director in the Office of...strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion… more
- J&J Family of Companies (Horsham, PA)
- …Medical Affairs programs/activities globally. Key Responsibilities: + Develop Global Medical Affairs strategy and plan for the assigned compounds based on ... Johnson & Johnson is recruiting for a Global Medical Affairs Leader (GMAL), Director - Dermatology in our...Excellent knowledge of study execution, benefit risk management and regulatory affairs highly preferred + Proven ability… more
- J&J Family of Companies (Horsham, PA)
- …study/clinical methods, study execution, data analysis & review, benefit risk management and regulatory affairs is highly preferred + Highly innovative with the ... Johnson and Johnson is recruiting for a Global Medical Affairs Leader (GMAL), Director - Gastroenterology within our...such as WHO, CDC etc. + Development of GMA strategy and plan for the assigned compounds (whether in… more
- Abbott (Princeton, NJ)
- …Affairs (GMSA), Abbott Point of Care + Contribution to global Medical & Scientific Affairs strategy in conjunction with Directors of EMEA and APAC Medical ... scientific dissemination of information + Cross-functional collaboration/interaction with Clinical Affairs , R&D, Regulatory , Quality, OEC, Legal, Global… more
- Taiho Oncology (Princeton, NJ)
- …functions at Taiho such as: Clinical Development, Commercial, HEOR, Market Access and Regulatory Affairs , Patient Advocacy, TOE, TPC and global teams to ensure ... Medical Director , Medical Affairs Princeton, NJ, USA...to achieving corporate objectives while maintaining the highest ethical, regulatory , scientific standards and meaningful differentiation for medical practice… more
- Sumitomo Pharma (Trenton, NJ)
- …dynamic culture. + Aligning with CMO, and VP of MA, to drive medical affairs strategy for Sumitomo Pharma America Inc. + Provide input to Global/Sumitomo ... us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** The **Executive Director Head of Medical Strategy ** will be… more