- Eli Lilly and Company (Indianapolis, IN)
- …them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use ... oral products CMC science and manufacturing processes. Knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years… more
- Merck & Co. (Upper Gwynedd, PA)
- … product and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting ... issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible ... fit for purpose and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …candidate will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC , and Clinical Development to ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Katalyst HealthCares and Life Sciences (Trenton, NJ)
- …Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams. Participate in global regulatory ... relevant line functions and with minimal supervision. Responsible for the global regulatory evaluation of CMC change controls with supervision. Responsible… more
- Katalyst HealthCares and Life Sciences (Cambridge, MA)
- …requirements and standards are properly and timely implemented. Provide support to Regulatory CMC managers in developing strategy for development projects, ... in CMC project team meetings and provide Regulatory CMC support as needed, including update...ability to multi-task and to work in a fast-paced global environment. bility to work under pressure to meet… more
- Cytel (Cambridge, MA)
- …with cross-functional teams, including analytical scientists, process engineers, and regulatory affairs , to develop and implement appropriate statistical ... Bayesian analysis experience and had exposure to Chemistry, Manufacturing, and Controls ( CMC ) data analysis. You are excited and enthusiastic, motivate your teams to… more
- System One Holdings, LLC (Florham Park, NJ)
- …with established timelines and submission dates in compliance with local and global regulatory requirements for the different application types (eg, IND, ... documents for electronic submissions. Coordinate with cross-functional teams, including Regulatory Affairs , Clinical Development, and Quality Assurance, to… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …Leadership : Provides strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs ... engineering, analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs . Advanced understanding in DMPK, Pharmacology… more
- Barrington James (Madison, OH)
- …regulatory interactions. Cross-Functional Collaboration Partner closely with Clinical Operations, Regulatory Affairs , Program Management, CMC , and ... clinical or medical affairs teams. Demonstrated track record in leading global clinical trials and progressing programs through regulatory milestones. Deep… more
- Takeda Pharmaceuticals (Boston, MA)
- …activities. Proactively recognizes and contributes to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report ... to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Plan, execute and manage regulatory submissions for assigned… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages the ... + Ensures department has broad technical knowledge and expertise in global CMC regulatory requirements and guidelines for conducting clinical trials,… more
- Lilly (Indianapolis, IN)
- …need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical ... molecules and/or synthetic peptides, proteins or oligonucleotide. + Knowledge of global CMC regulatory requirements and guidelines for reporting post… more
- Lilly (Indianapolis, IN)
- …who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC ... synthetic molecule CMC drug development science(s). + Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …years) required. + Highly proficient understanding of scientific principles and profound grasp of global regulatory CMC requirements relevant to global ... + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for...CMC knowledge underpinned by a deep understanding of global drug development and regulatory essentials to… more
- Lilly (Indianapolis, IN)
- …+ Deep technical knowledge of CMC drug development science(s) + Knowledge of CMC global regulatory requirements and guidelines related to parenteral drug ... knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for... global regulatory expectations + Provide regulatory guidance to allow CMC development teams… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ A scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs , and CMC ... serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics...+ Lead the execution and influence the development of global CMC regulatory strategies, including… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …+ Responsible for the strategic company guidance on FDA and global regulatory requirements ( affairs and CMC ) for investigational and commercial products ... leadership and oversight to the development of innovative regulatory affairs and CMC ...Responsible for the strategic company guidance on FDA and global regulatory CMC requirements for… more
- J&J Family of Companies (Spring House, PA)
- … activities within the Chemistry, Manufacturing, and Controls ( CMC ) area of Global Regulatory Affairs . This position will involve collaboration with ... communications in line with global product strategy. + Alert CMC Regulatory Affairs Management to issues affecting registration, compliance, and product… more
