- 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
- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance ... all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory...of related experience regulated industry or health authority + Senior Director : 20+ years of related experience… 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
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. ** Senior Advisor/ Director , Global Regulatory Affairs - CMC , Small Molecules** At Eli ... medicines to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Small Molecules will leverage … more
- Merck (North Wales, PA)
- **Job Description** Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing ... regulatory strategies and provides mentoring and coaching to Sr . Scientist and Assoc Principle scientist in support of...but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide … more
- Takeda Pharmaceuticals (Boston, MA)
- …GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. **How you ... regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM… 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
- Bristol Myers Squibb (Princeton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . Sr . Director , Statistical Programming provides technical leadership to portfolio ... delivery and building / retaining highly skilled talent in Statistical Programming. Sr . Director , Stats Programming, proactively creates and implements delivery… 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)
- …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
- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- AbbVie (Madison, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager, Global Regulatory Strategy, US & Canada, AbbVie Inc., ... within a Therapeutic Area and support the Manager, Global Regulatory Lead (GRL), Associate Director , or ...response to Health Authorities during application review. . Support CMC sections of major, complex regulatory submissions,… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports . Work is performed under direction of a Senior Regulatory Affairs professional Contribute to internal regulatory policies and ... The Director , Regulatory Affairs will be responsible...Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC … more