- Bayer (Cambridge, MA)
- …clinicians, clinical operations, bioanalysis, biomarker specialists, pharmacometrics, pharmacovigilance, regulatory affairs, statistics, and PS ( CMC ) groups. ... clinical operations, data management, pharmacometrics, medical writing statistics), pharmacovigilance, PS ( CMC ), regulatory affairs to best use CP concepts… more
- Takeda Pharmaceuticals (Boston, MA)
- …to regulatory filings/submissions on request + On occasion will QC selected CMC sections of regulatory filings + Project team participation as necessary, ... with pharmaceutical product/process development, regulatory guidelines and experience in regulatory submissions (in particular CMC Module 3 information and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Development, Regulatory , Quality, and external partners (CROs/CDMOs) to achieve CMC objectives and meet program timelines. + Represent Analytical Development on ... cross-functional teams. + Author and review CMC documents for regulatory submissions and address global health authority questions. **What You Bring to Takeda**… more
- ManpowerGroup (Andover, MA)
- …organization for both early and late stage product development teams inclusive of CMC regulatory submission support. Early phase support will include the ... development and management of project plans in Planisware and will include forecasting both short and long term project resource projections (FTE's and Financials). . Late Stage support is focused primarily on developing and managing project execution plans… more
- Sanofi Group (Framingham, MA)
- **Job title** : Digital Product Owner CMC E2E DSP **Location:** Framingham, MA **About the Job** At Sanofi, we're committed to providing the next-gen healthcare that ... iCMC Digital Transformation is a global top initiative that aims at building competitive CMC capabilities and enabling a digital continuum for R&D and M&S data. It… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). + Minimum of 5 years' experience as… more
- Amgen (Cambridge, MA)
- …team lead to author technical reports and analytical Chemistry, Manufacturing and Controls ( CMC ) sections in regulatory documents. + May lead and develop a ... communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, eg informing and defending the Quality Target… 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 Research ... and Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than...Lead for Specialty Care Combination Products will oversee key regulatory activities and report to the GRA Device Team… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Amgen (Cambridge, MA)
- …Interpret results, author technical protocols, reports, analytical method descriptions and analytical CMC sections in regulatory documents + Lead project teams ... transfer and validation. + Experience in authoring and review of regulatory submission product quality sections and supporting documentation. Experience preparing… more