- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages ... strategies for both development and commercial products. Additionally, the Senior Director is committed to encouraging continuous improvement in regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Budget management and sign off at Assoc. Director authorization level, CMC -DP strategy development , implementation, and vendor selection + Author, review, ... knowledge. **Job Description** **Objective:** Under the direction of the Director or Sr . Director , ODPD,...hardness, etc. + Must be able to apply product development expertise to CMC sections of the… more
- Amgen (Washington, DC)
- …Amgen team. Join us and transform the lives of patients while transforming your career. Senior Director , CMC Statistics **What you will do** Let's do this. ... pipeline and commercial products across different therapeutic areas. The Senior Director , CMC Statistics, will...the design, analysis and reporting for all phases of CMC development across multiple functional and organizational… more
- Lilly (Indianapolis, IN)
- …solutions to support communities through philanthropy and volunteerism. **Position Summary:** The Senior Director , CMC Project Management will provide ... therapeutic areas to translate clinical, asset and portfolio strategy into clear CMC development and delivery goals for cross-functional CMC teams. + Lead… more
- Lilly (Indianapolis, IN)
- …to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage ... based upon global regulatory changes. + Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product… more
- Lilly (Indianapolis, IN)
- …a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content for registration, post-approval ... life-changing new medicines to patients who need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - … more
- Takeda Pharmaceuticals (Lexington, MA)
- …proficient understanding of scientific principles and profound grasp of global regulatory CMC requirements relevant to global drug development and post-market ... This role is within in the R&D GRA Chemistry Manufacturing & Controls ( CMC ) and Devices organization, and will contribute to the team's delivery of critical… more
- Bristol Myers Squibb (Indianapolis, IN)
- …the global leader in radiopharmaceuticals . We are seeking an experienced and motivated ** Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This ... and Marketing Authorization Application (MAA) submissions + Lead the development and execution of global CMC regulatory...care resources. Other perks like tuition reimbursement and a recognition program. If you come across a role that… more
- BeOne Medicines (Emeryville, CA)
- …of relevant pharmaceutical or biopharmaceutical industry experience in innovative drug CMC development , manufacturing, Quality, etc. including minimum 8 years ... team in US. * Lead or/and oversee the development and implementation of biologics regulatory CMC ...needed throughout product lifecycle. Escalate the critical issues to senior management timely. * Lead or/and oversee the establishment… more
- Gilead Sciences, Inc. (Foster City, CA)
- …guidances, comments on draft regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior management. + Provides ... member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we… more
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