- dsm-firmenich (Princeton, NJ)
- ** Lead Expert Regulatory Affairs Pet Food** **Location: Plainsboro, NJ** **Hybrid** Are you a junior Regulatory Affairs professional ready to ... in this niche space where you can learn and grow. We are hiring a Lead Expert Regulatory Affairs Pet Food to support our Taste Texture and Health (TTH)… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **Summary:** The Associate Director, Regulatory Affairs - Regulatory Project Management (RPM) provides ... Associate Director RPM is responsible for supporting the global regulatory lead (GRL), US regulatory ...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 **Director Regulatory Affairs ** . The Director is part of the Global ... Regulatory Affairs (GRA) team based in the...I-IV Research & Development Activities + As a Regional Regulatory Lead , manage regional (United States and/or… 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 ... disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT)...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Sumitomo Pharma (Trenton, NJ)
- …of scientific and medical information for key stakeholders. The Vice President will lead the global medical affairs functions for investigational and marketed ... medical affairs activities for investigational and marketed products. + Lead development of systems and processes to ensure harmonized and integrated medical… 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 + ... assigned indications. Position Summary: The Sr. Medical Director, Medical Affairs (SMD, MA) needs to be an expert...clear understanding of all areas and functions within medical affairs and able to lead strategic development… more
- Sumitomo Pharma (Trenton, NJ)
- …and responses to unsolicited requests for medical/scientific information. + Serves as Medical Affairs Lead on select therapeutics topics, and provides input into ... management peri-, pre-, and post-launch activities related to Medical Affairs function. This individual will lead program...Product Development Monthly Meetings. + Serve as Subject Matter Expert within Medical Affairs Team provide medical… more
- Sanofi Group (Bridgewater, NJ)
- …experience partnering with cross-functional teams is strongly preferred (eg, Medical, Regulatory Affairs , Market Access, Communications). + This position may ... Affairs Head, Hemophilia serves as a public affairs (PA) expert to the Rare Diseases...value for the organization. + Take ownership, rally and lead the cross-functional team on public affairs … 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. The job ... external facing HCP and Payer interactions. The Sr. Director of Medical Affairs develops and maintains professional relationships with key physicians and other… more
- Sumitomo Pharma (Trenton, NJ)
- …and experienced individual for the position of **Senior Manager, Medical Affairs Technology and Digital Innovation** . **Job Duties and Responsibilities** + ... Supports the development, implementation, execution, and oversight of Medical Information/Medical Affairs digital services and innovative digital projects as well as… more
- Sanofi Group (Bridgewater, NJ)
- …what you thought was possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL), you will be the fully accountable ... **Job title: Global Regulatory Lead ** + Location: Bridgewater, NJ...in R&D, including at least 10 years of relevant Regulatory Affairs experience (regionally and/or global), in… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …is highly preferred + Advanced education or credentialing in regulatory affairs and project management preferred Demonstrated expert experience leading high ... and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners... organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory… more
- Novo Nordisk (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... experiment with us? The Position The HCP - Strategy Lead (MASH) lead will be a pivotal...cycle activities + Health Systems strategy: Collaborates with medical affairs and market access teams to inform a health… more
- Novo Nordisk (Plainsboro, NJ)
- …Access and Public Affairs (MAPA), Portfolio Strategy, Commercial Excellence, Regulatory Affairs , and other relevant NNI departments to ensure alignment ... our future. The Position The Rare Bleeding Therapeutic Area Lead is instrumental in shaping and executing NNI's strategic...outcomes + Product Evolution + Oversee product strategy and regulatory activities related to new clinical data or label… more
- Ascendis Pharma (Princeton, NJ)
- …medical information system development. + Serve as a clinical and scientific expert for Medical Affairs projects within the designated TransCon Program(s). ... is a major advantage. The candidate is expected to lead key strategic, cross-as well functional projects as part...both internal and external audiences within legal, compliance and regulatory guidelines. + Represent Ascendis Medical Affairs … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other...disorders. **Summary** This position serves as the GRA labeling expert to the Global Regulatory Team (GRT)… more
- Taiho Oncology (Princeton, NJ)
- …and oncology, the Director, External Research will enjoy collaborating with Medical Affairs Product Leads on development of the areas of interest, execution of ... monitoring and reporting of key milestones. In addition to interactions with Medical Affairs Product Leads, this role will engage with Medical Field team, global… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Edwards Lifesciences (Trenton, NJ)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for developing the strategy ... partnership with external stakeholders like KOLs,/HCPs, academic medical institutions, and regulatory authorities, you will support driving the evidence needed to… more
- Novo Nordisk (Plainsboro, NJ)
- …the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and ... + Support the ALD clinical development program as medical lead and expert drug developer, providing input...Non-Clinical Research, Medical Writing, Program Management, Product Supply and Regulatory Affairs teams to deliver and drive… more