- Deloitte (Boston, MA)
- …serve + Limited immigration sponsorship may be available Preferred: + Understanding of pharmaceutical regulatory data and regulatory filing requirements and ... analytics solutions + 4+ years of experience with Life Sciences Pharmaceutical R&D regulatory data lifecycle . Experience to include introducing new technologies… more
- Cardinal Health (Mansfield, MA)
- …ICH guidelines, FDA regulations, Data Integrity, Quality Risk Management and other pharmaceutical regulatory requirements, preferred. + Working knowledge of ... as LabWare. + Possesses significant working knowledge of USP, FDA and ICH regulatory requirements as applicable to pharmaceutical stability testing. + Possess a… more
- Takeda Pharmaceuticals (Boston, MA)
- …including Tetrascience, QbDVision, PAS-X, SAP or Databricks + Understanding of regulatory standards in pharmaceutical industry **Behavioral Competencies:** + ... to putting patients first. As the Director, Technology Business Partner for Pharmaceutical Sciences R&D Data Digital and Technology (R&D DDT), you will serve… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ 10+ years of overall biopharmaceutical/device industry experience with 8+ years pharmaceutical Regulatory CMC and / or devices experience, while leading ... products as GRA CMC Product Lead. + Represents and contributes to Regulatory , Pharmaceutical Development, and Commercial project teams throughout clinical… more
- Stryker (Boston, MA)
- …disposition and release in addition to Quality Assurance responsibilities.Viewed as pharmaceutical regulatory expert within business. + Leads communication with ... aspects in external agency audits/inspections. + Stays abreast of external pharmaceutical regulatory requirements and expectations. **Education & Special… more
- Cardinal Health (Mansfield, MA)
- …protocols and reports. + Possesses working knowledge of USP, FDA and ICH regulatory requirements as applicable to pharmaceutical stability testing is desired. + ... the chemistries of our medical device products and stability testing for pharmaceutical products of Cardinal Health. Chemistry Services is a part of Quality,… more
- ThermoFisher Scientific (Waltham, MA)
- …and communicate the impact of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical product development in the area ... helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager, Regulatory Affairs, you will play a crucial role in interpreting and disseminating… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- … intelligence and collaborates with SMEs to interpret the impact of regulatory changes to the pharmaceutical environment. **Job Description** + Oversee ... The Associate Director of Regulatory Intelligence leads the collection and dissemination of...new and updated regulations and guidance that may impact pharmaceutical practices, procedures and controlled documents. + Lead weekly… more
- Sanofi Group (Framingham, MA)
- …within our GRA CMC & GRA Device Organization, you'll drive global regulatory strategies for pharmaceutical and vaccine products, collaborate with ... the CMC Lead role offers the opportunity to drive regulatory strategy for pharmaceutical products and vaccines across their lifecycle. Working at the… more
- GRAIL (Boston, MA)
- …clinical affairs, quality, or program management within the IVD, medical device, or pharmaceutical industries is required. + Regulatory affairs and IVD device ... Regulatory Affairs Certification (RAC) preferred. + Experience in pharmaceutical clinical, statistical, or regulatory settings-especially in oncology,… more
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