- Merck & Co. (Rahway, NJ)
- Job Description Director, Combination Product Regulatory CMC - (R5)- - - This Principal Scientist position is equivalent to a Director position. Under direction ... from the Combination Product Regulatory CMC Team Leader, the Principal Scientist...Capability, People Leadership, Policy Implementation, Project Management, Project Tasks, Regulatory Affairs Compliance {+ 4 more}-Preferred Skills:Job… 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. (Rahway, NJ)
- …position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility ... combination quality system aspects are integratedStay abreast of evolving global regulatory landscapes for medical device and...Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC , … 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
- 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)
- …them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use ... products CMC science and manufacturing processes. + Knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes… 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
- Lilly (Carolina, PR)
- …world. The Sr. Principal Scientist **or** Advisor Post Approval Scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC ... products CMC science and manufacturing processes. + Knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes… 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
- Sanofi Group (Cambridge, MA)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director) **Location** : Cambridge, MA or… 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
- Sanofi Group (Morristown, NJ)
- …collaboration with R&D functions, Industrial Affairs , Global Regulatory Affairs . + Coordinate the submission of CMC regulatory files and ... (new products or marketed products) in collaboration with all Global Regulatory Affairs entities. +...allotted. + Author the CMC strategy document " Global Regulatory CMC Strategy Document"… more
- Lilly (Indianapolis, IN)
- …provide and maintain the interface between Product R&D Quality Assurance and Global Regulatory Affairs for CMC (GRACMC). + Ensuring that the internal ... Material Specification Packages (MSP) are in alignment with all global regulatory documents and commitments. + The...including QA batch release in a clinical trial environment, regulatory affairs ( CMC ), or clinical… more
- Sanofi Group (Morristown, NJ)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... and Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than 1800...perspective as a member of project specific cross functional global regulatory team (GRT) and is accountable… more
- Bristol Myers Squibb (Indianapolis, IN)
- …Marketing Authorization Application (MAA) submissions + Lead the development and execution of global CMC regulatory strategies for activities conducted at ... We are seeking an experienced and motivated **Senior Director, Regulatory Affairs - CMC (Manufacturing)**...global change management + Provide additional ad hoc Regulatory - CMC support to RayzeBio manufacturing team +… more
- Gilead Sciences, Inc. (Foster City, CA)
- … regulatory guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs , and affiliates on internal ... + Bachelor's degree and 12+ years of experience in CMC Regulatory Affairs ( CMC...+ A proven track record of developing and leading global CMC regulatory submissions strategies… more
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