- 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 ... filing 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 ... the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and Promotion is responsible for providing… 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...pharmaceutical industry with minimum of 6 years focused in Regulatory Affairs + Include the qualifications preferred… 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...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …application is true to the best of my knowledge. **Job Description** The Regulatory Affairs -Labeling, Associate Director is responsible for ensuring that ... pertaining to global and local labeling compliance and quality within Global Regulatory Affairs . + Partners with internal stakeholders and external CRO… 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 ... ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US Regulatory PMs… 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 in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... 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. (Basking Ridge, NJ)
- …or More Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the ... 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. (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)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… 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 managing, coordinating, tracking and follow-up on FDA Communications and ANDA status for assigned… 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 ,...confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and procedures, by ensuring… more
- Sumitomo Pharma (Trenton, NJ)
- …Director , Medical Strategy (Rare Disease) will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... company programs and external facing HCP and Payer interactions. The Sr. Director of Medical Affairs develops and maintains professional relationships with… more
- Taiho Oncology (Princeton, NJ)
- …such as: Clinical Development, Commercial, Evidence and Value Development, Market Access and Regulatory Affairs to ensure, as needed, alignment and inputs + ... Sr. Medical Director , Medical Affairs Princeton, NJ, USA...to achieving corporate objectives while maintaining the highest ethical, regulatory , and scientific standards. Performance Objectives: + Strategically work… more
- Sumitomo Pharma (Trenton, NJ)
- …, Medical Strategy (Prostate Cancer)** will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... initiatives and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs. **Job Duties and Responsibilities**… more
- Sumitomo Pharma (Trenton, NJ)
- …. **Job Overview** Associate Director , Field Medical and Scientific ... summarizes, and disseminates key insights obtained from the RDs to the Medical Affairs and other internal stakeholders in a timely manner. + Participate in the… more
- LS Power Development, LLC (East Brunswick, NJ)
- …parental leave and more. **About the Role:** We currently have an opportunity for a Manager/ Director of Government Affairs that can be based in our New Jersey or ... and advocacy strategies.As a member of LS Power's government affairs team, you will be responsible for designing and...in which we operate assets. + Develop legislative and regulatory strategies that are clearly aligned with business +… more