- Highmark Health (Boston, MA)
- …position serves as a key liaison between Claims Operations, Customer Service, Regulatory Affairs , IT, Legal and other departments, proactively identifying, ... assessing, and mitigating compliance risks. The Analyst will monitor regulatory changes, interpret their impact on operational processes, and implement effective… more
- Sumitomo Pharma (Boston, MA)
- … Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as ... the Regulatory reviewer for assigned products. This position is responsible...eg Marketing and their Agencies, Legal, Compliance, and Medical Affairs . + Provide appropriate oversight of promotional material review… more
- Beth Israel Lahey Health (Plymouth, MA)
- …latest trends in field of expertise especially related to health care quality, regulatory affairs , organizational behavior and leadership + Performs all duties ... Plymouth Hospital. The CMO is responsible for the overall medical and administrative affairs related to health care delivery and medical staff management of patient… more
- Republic Services (Norwood, MA)
- …management, coordination of meetings for large regulatory projects. + Supports the Regulatory Affairs management in project tasks as they arise. + Performs ... **POSITION SUMMARY:** The Regulatory Coordinator provides administrative support with regulatory...The Regulatory Coordinator provides administrative support with regulatory compliance matters including but not limited to maintaining… more
- Sanofi Group (Cambridge, MA)
- …qualified with: + Min 15 years of experience working in clinical development and/or regulatory affairs + Min 10 years of leading an internationally dispersed ... of sanofi revenues by expediting submission timelines and facilitating reviews by regulatory agencies of sanofi key assets. + He/she: Creates and executes a… more
- Takeda Pharmaceuticals (Boston, MA)
- …Japan Payer Marketing and Market Access, Global Evidence and Outcomes, Medica Affairs , Clinical Development, Regulatory Affairs , Biostatistics, Global ... + Market Access, Pricing, Advocacy, Biostatistics, Global Evidence and Outcomes, Medical Affairs , Clinical Science, Legal, Regulatory + OBU 10, EUCAN, GEM… more
- Takeda Pharmaceuticals (Boston, MA)
- …analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs . Advanced understanding in DMPK, ... Guidelines, other pertinent national regulations, compendial requirements and communicating with regulatory agencies. + Must have experience in global regulatory … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs . + Advanced knowledge of regulatory ... approaches (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in meetings with global or… more
- ThermoFisher Scientific (Cambridge, MA)
- …bioreactors (SUBs), wave reactors preferred. Demonstrated knowledge of cGMPs/GLP or regulatory affairs pertaining to the pharmaceutical and biological industries ... is preferred. Knowledge of gene therapy product and/or process development preferred. Excellent problem solving and critical thinking skills, including strong attention to detail. Advise supervisor of factors that may affect quality, accuracy, timeliness, and… more
- Dana-Farber Cancer Institute (Boston, MA)
- …levels of an organization. + Regulatory Expertise: Strong knowledge of regulatory affairs , research ethics, and the responsible conduct of research, with ... a preference for candidates who demonstrate expertise in these areas. + Computer literacy: Proficient with new applications and software programs, including Endnote. Proficiency with Excel/Google Sheets preferred. + Organization: Proficient with electronic… more