- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as an Senior Manager , Global Regulatory Affairs, CMC Small Molecules where you will ... business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How… more
- AbbVie (North Chicago, IL)
- …Chemistry, Manufacturing, and Controls ( CMC ) strategic project plans to support CMC regulatory deliverables such as INDs/IMPDs and Marketing Applications. ... YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Program Manager , CMC Dossier Management assists with the development and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a ... Senior Manager of Statistics, you will provide statistical leadership in...design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an… more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… more
- ThermoFisher Scientific (Grand Island, NY)
- …to all Good Manufacturing Practices (GMP) Safety Standards, Office **Job Description** The Sr . Manager , Regulatory Affairs - Drug Support Strategy is ... as customer and employee needs. The Sr . Manager will develop and pursue world-class regulatory ...regulatory standards + Provide strategic mentorship on applicable CMC regulatory submissions and support for customers… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager , Supply Chain leads, develops, establishes, and manages the ... working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, Finance,… more
- ThermoFisher Scientific (Greenville, NC)
- …of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. + ... show the above in your submittal to be considered)** ** Senior Director Project Mgmt - Oversight** At Thermo Fisher...in the Con Mod process. + Communicates with People Manager (s) to support the development of the employee providing… more
- MD Anderson Cancer Center (Houston, TX)
- …and preclinical research protocols. Work practices must be in compliance with regulatory requirements. The Senior Radiochemist will also provide guidance and ... the public. **SUMMARY ** The primary purpose of the Senior Radiochemist position is the responsibility for the safe...critical inputs on new ideas and approaches with Lab Manager or Director. ** Regulatory Responsibilities** * Follows… more
- Gilead Sciences, Inc. (Foster City, CA)
- …our team, **Biologics Pre-Pivotal Formulation and Process Development** , as a ** Senior ** **As** **sociate Scientist** . The successful candidate will contribute to ... documentation practices. . Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
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