- Takeda Pharmaceuticals (Boston, MA)
- …of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with ... the following requirements: Master's degree in Regulatory Affairs or related field plus 2...working in close coordination with the quality, manufacturing and global regulatory teams; Ensure the response to… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program ... leadership and develop CMC regulatory strategy for global ...regulations and guidelines by applying interpersonal skills and expert Regulatory Affairs Vaccines (RAV) CMC … more
- Editas Medicine (Cambridge, MA)
- …in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory requirements and ensure that project team colleagues and ... + Accountable for the management and delivery of all CMC regulatory milestones, including global ... affairs and a minimum 8 years in CMC regulatory affairs . + Experience… more
- Takeda Pharmaceuticals (Boston, MA)
- … Pharmaceuticals regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post ... you will report to the Executive Director and Head, CMC Regulatory Affairs , Pharmaceuticals. **How...international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global… more
- Sanofi Group (Cambridge, MA)
- ** Global Regulatory Affairs Lead...and late stage development of multiple modalities; experience within regulatory CMC not directly applicable + ... (GRL)** **Mission statements** + The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for the development & execution of… more
- ConvaTec (Lexington, MA)
- …regulatory strategy and registration across global markets across the entire Regulatory Affairs group. Individuals will be expected to help drive ... Summary: The primary responsibilities of the position are to drive improvements in regulatory affairs processes, systems and infrastructure whilst supporting … more
- Sanofi Group (Cambridge, MA)
- We are currently seeking a Global Regulatory Affairs Lead (GRL) who will be the fully accountable decision maker for the development & execution of creative, ... of relevant pharmaceutical/biotechnology experience, including at least 6 years of relevant Regulatory Affairs experience (regionally and/or global ), in… more
- Sanofi Group (Cambridge, MA)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global ) especially ... post-marketing activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… more
- Sanofi Group (Cambridge, MA)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global ) especially ... activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner...strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with… more
- Takeda Pharmaceuticals (Boston, MA)
- …to senior management to plan, evaluate and recommend implementation strategy. As part of the Regulatory Affairs CMC team, you will report to the Executive ... Director and Head, CMC Regulatory Affairs - Pharmaceuticals....regulatory team in the development and implementation of global CMC regulatory strategies during… more
- Bristol Myers Squibb (Cambridge, MA)
- …areas of exploratory development, including chemistry/biochemistry, biology, toxicology, CMC , translational medicine, early clinical development, regulatory , ... personal lives. Read more: careers.bms.com/working-with-us . **Position:** Vice President, Global Program Lead Neuroscience **Location** : Princeton Pike Site in… more
- Sumitomo Pharma (Boston, MA)
- …The Associate Director ensures compliance with GMPs, SMPA procedures and applicable global Regulatory guidelines by providing oversight and management of the ... changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed. + Responsible for compliance with… more
- Novo Nordisk (Lexington, MA)
- …including Non-Clinical Research, Bioanalytics, Clinical Operations, Medical Writing, Program Management, CMC and Regulatory Affairs . Interfaces with both ... to develop new medicines for patients. The Position The Global Nucleic Acid Therapies (GNAT) Early Development (ED) unit...as Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC , and Regulatory Affairs to… more
- Sanofi Group (Framingham, MA)
- …in collaboration with internal and external partners. + Develop strategies in collaboration with Global Regulatory Affairs as well as the Business Unit ... pharmaceutical industry in R&D and/or industrial development, industrial operations and GMP considerations, global CMC projects. 15 to 20 years of experience in… more
- Novo Nordisk (Lexington, MA)
- …VP Medical/Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be ... requirements + Work with, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and… more
- WuXi AppTec (Boston, MA)
- …needs in TIDES drug development from discovery through clinical to commercial. Moreover, our Regulatory Affairs CMC team is experienced in preparing CMC ... drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under one roof. With over… more
- Randstad US (Cambridge, MA)
- …+ Knowledge of pharmaceutical industry and Project management experience within Medical Affairs , Clinical Research, Regulatory , CMC , Marketing or other ... at the MST are reported up through to the Global Program Manager at the GPT for consolidation into...program level budgets across multiple projects + Knowledge of regulatory and compliance guidelines governing medical affairs … more