- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... within overall CMC development project(s), to support Sr CMC Lead. In case no ...preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …biologics and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory - CMC function and corporate affairs as needed. In the short ... is compatible with DS' strategic objectivesWork with other DS functions (incl. Regulatory - CMC ) to coordinate Regulatory Intelligence activities and ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …this role, the incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the ... Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing… more
- Insmed Incorporated (Bridgewater, NJ)
- …DABT/DACVP certification preferred. Minimum of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewOverview The Director , Toxicology, is a key member of the nonclinical safety team,… more
- Novo Nordisk Inc. (Boulder, CO)
- …small molecules and oligonucleotide products. Relationships This position reports to Senior Director , Chemical Development. Essential Functions Lead the ... in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical...ready to make a difference? The Position The Associate Director , Process Chemistry will be responsible for the design,… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …strategy, which integrates scientific rationale, clinical development, nonclinical development, regulatory , medical, commercial input, CMC , legal and other ... a focus on deep science and innovation, with speed and potential program and regulatory uncertainty or risks as well as maximizing over value for our patients. The… more
- Gilead Sciences, Inc. (Foster City, CA)
- …operates in more than 35 countries worldwide, with headquarters in Foster City, California. ** Sr Director , CMC Regulatory Affairs -Small Molecules** ... **KEY RESPONSIBILITIES** The Sr Director , CMC Regulatory Affairs for Small Molecules is responsible for managing a team of professionals, who work with… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC ...Manager, Manager & Associate III). The Sr Director , Regulatory Affairs CMC is ... analytical methods, formulation development, manufacturing, and labeling. The Sr Director , Regulatory Affairs CMC is also responsible for the oversight… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA Pharmaceuticals- Small Molecule where...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… more
- Lilly (Philadelphia, PA)
- …and cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory , manufacturing, and supply chain teams, to ensure ... budget, and resource allocation, and provide regular updates to senior management. + Lead other tasks / projects as...projects and programs. + Advanced understanding of cGMPs and CMC regulatory requirements + Ability to manage… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... within overall CMC development project(s), to support Sr CMC Lead. In case no ...- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or… more
- Gilead Sciences, Inc. (Foster City, CA)
- …headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES The Sr Director , Analytical ... to operate" throughout the product lifecycle. In addition, the Sr Director will be accountable for leading...leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Sr Director , Global Launch Readiness - Immunology Date: May 25, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: ... messaging, positioning, creative campaign development and regional alignment/coordination). The Senior Director , Global Launch Readiness Immunology will be… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director , Biologics Drug Product MSAT** Gilead Sciences, Inc. is ... stakeholders. Collaborate with CMOs, Quality Control, Quality Assurance, External Manufacturing, Regulatory CMC , Process Development, Supply Chain and other… more
- Lilly (Cambridge, MA)
- …significant improvements in healthy outcomes for our customers. We are seeking an Executive/ Senior Director - DDCS Drug Delivery and New Product Innovation to ... the Medicines Innovation Hub and the Business Units, as well as leaders in Regulatory and Manufacturing to define and deliver our strategy. This individual will be… more
- Lilly (Indianapolis, IN)
- …better for people around the world. Purpose: The purpose of the Senior Director /Executive Director , Global Regulatory Affairs, Global Regulatory Lead ... development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area + Knowledge of Global… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …managers, medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). **A ... The ** Sr Manager, Clinical Drug Supply & Logistics** is...IP expiry. + Coordinates with other functional areas, including Regulatory , Medical Director , Forecasting & Planning, and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …biologics and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory - CMC function and corporate affairs as needed. In the short ... with DS' strategic objectives + Work with other DS functions (incl. Regulatory - CMC ) to coordinate Regulatory Intelligence activities and ensure regulatory… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs, is responsible for the ... marketed products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs,...Commercial Regulatory Affairs, in collaboration with Head, Regulatory Affairs and CMC -RA, will review and… more
