- ManpowerGroup (Waltham, MA)
- …team. As a Veeva Vault RIM SME, you will be part of the Regulatory Affairs department supporting cross-functional teams. The ideal candidate will demonstrate ... Strong knowledge of any Vaults within RIM.** **What's the Job?** + Manage regulatory workflows within the Veeva Vault RIM system to ensure compliance and efficiency.… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- ThermoFisher Scientific (Waltham, MA)
- …across IVD assays, instruments, and software. You'll partner closely with R&D, Clinical Affairs , Regulatory Affairs , and Operations to design and analyze ... studies that directly support regulatory submissions and improve patient outcomes. **A Day in...(PPA, NPA, PPV, NPV) and deliver analyses to support regulatory filings. + Generate tables, listings, and figures aligned… more
- Takeda Pharmaceuticals (Boston, MA)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , Marketing, ... strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees. + Ensure communication of all safety… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Director May Be… more
- Merck (Boston, MA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Clinical Director May Be… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director May… more
- Sanofi Group (Cambridge, MA)
- …Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy ... scientists in the project in collaboration with the Safety Officer, Regulatory Strategist, Statistics and other key functional representatives to deliver development… more
- Bristol Myers Squibb (Cambridge, MA)
- …(Masters, PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** ... personal lives. Read more: careers.bms.com/working-with-us . **Associate Director, Global Regulatory Strategy, Neuroscience** **Position Summary:** The selected candidate will… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides ... to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for all the… more