- 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
- 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 (Cambridge, MA)
- …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
- Fresenius Medical Center (Waltham, MA)
- …+ 12+ years of experience in regulatory affairs , focusing on regulatory strategy, submissions, and global market access in the pharmaceutical industry. + ... clinical/medical, CMC , and post-market phases. + Monitor regulatory trends, updates, and guidance from global ...a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred.… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Sanofi Group (Cambridge, MA)
- …with all key stakeholder in GPT and Global Brand Team (GBT) + Defines global project plans and regulatory strategy together with the GPT members; leads the ... R&D components of the brand optimization strategy in close collaboration with Market Access, Global Commercial and Medical Affairs , as Active member of GPT. +… more
- Sanofi Group (Cambridge, MA)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regional and global ), in early ... teams accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner...and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated… more
- Cardinal Health (Boston, MA)
- **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product ... approvals. More specifically, this role serves the function to support global , post-approval lifecycle regulatory requirements for Biologics and small-chemical… more
- Takeda Pharmaceuticals (Boston, MA)
- …**:** + Provides strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs that ... engineering, analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs . Advanced understanding in DMPK, Pharmacology… 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