- 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
- Merck & Co. (Rahway, NJ)
- …partner functions including Global Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs , as well as, the GBO Leadership ... Job DescriptionOur Global Biologics Operations (GBO) organization is responsible for...and training programs for site and functional teamsPartner with regulatory affairs , quality and site tech ops… 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
- Acadia Pharmaceuticals Inc. (Princeton, NJ)
- …is responsible for contributing to/assisting with the development and implementation of global regulatory CMC strategies supporting investigational and ... marketed small molecules therapeutics worldwide. Coordinates global CMC regulatory activities necessary... drug development and commercial activities. Primary Responsibilities Supports CMC regulatory affairs activities for… 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
- The Fountain Group (Cambridge, MA)
- …CMC expertise into the development and implementation of the global regulatory strategy, operations, and planning for the CMC aspects of assigned ... a national staffing firm and are currently seeking a Regulatory Affairs Manager III for a prominent...late-stage development or commercial programs. The Regulatory CMC Lead is the primary global contact… more
- Mirum Pharmaceuticals (San Mateo, CA)
- …real, get it done, and have fun, seriously. POSITION SUMMARY The Associate Director, Global Regulatory Affairs provides management of all aspects of assigned ... documents). In collaboration with Regulatory project managers, Regulatory Labelling and Regulatory CMC ,...pharmaceutical industry with a minimum of 8 years in Global Regulatory Affairs , experience with… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …and program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC , Marketing). Minimum of… more
- Glycomine (Boston, MA)
- …etc). Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs , Translational Medicine and Program Leadership to ... and working closely with relevant team members involved in study set up ( CMC , Reg, etc). Ensure timeline collection of all start-up documents (example ethics… more
- Legend Biotech US (Somerset, NJ)
- …Serve as a liaison between internal departments (eg, research, toxicology, pharmacology, CMC , regulatory affairs ) and eternal partners (eg CROs) ... Legend Biotech is a global biotechnology company dedicated to treating, and one...team, ensuring adherence to IND submission timelines, budgets and regulatory requirements and acting as central point of communication… more
- Vertex Pharmaceuticals (Boston, MA)
- …improvement. Interact with internal cross-functional teams, including Analytical Development, AS&T, CMC , Supply Management, Regulatory Affairs , Program ... with ICH/EMA/USP/Ph. Eur. Guidelines and internal procedures. Work with CMC technical SMEs and Regulatory to prepare...review QC related sections of IND, IMPD, BLA/MAA and global regulatory submissions and provide support in… 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)
- …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)
- …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
