- 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
- 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
- Takeda Pharmaceuticals (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… more