- Sanofi Group (Cambridge, MA)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regional and global), in early and ... **Job Title:** Regulatory Strategist **Location** : Cambridge MA/ Morristown, NJ...accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Manufacturing Sciences + Global Manufacturing Supply, Global Quality and Global Regulatory Affairs . + SME for Takeda drug product manufacturing organization ... and the life cycle management of existing products. You will lead regulatory interactions, including the preparation of Chemistry, Manufacturing, and Controls (CMC)… more
- Sanofi Group (Cambridge, MA)
- …including medical leads, global study lead, statisticians, clinical supply managers, regulatory affairs specialists, etc. + Ensures compliance with relevant ... regulations, such as Good Clinical Practice (GCP), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), internal SOPs. Propose update and improvements to the processes as relevant. + Pilot and implement any… more
- Hologic (Marlborough, MA)
- …Services globally. You will collaborate with key stakeholders, including Regulatory Affairs , Quality Assurance, Supplier Quality Assurance, Engineering ... Solutions Analyst, Global IT Quality Solutions** to join our **Quality, Regulatory , and Product Life Cycle Management Systems Center of Excellence (COE)**… more
- Genentech (Boston, MA)
- …will have strong collaboration with cross-functional teams, including clinical research, regulatory affairs , and product development, to ensure the successful ... require a strong understanding of cardiovascular diseases, clinical trial protocols, regulatory requirements, and possibly interactions with regulatory agencies… more
- Takeda Pharmaceuticals (Boston, MA)
- …with functional experts across the R&D organization, such QS, Research, Biostatistics, Regulatory Affairs , DMPK, Pharm Sci, and Clinical Science providing ... MBMA) across the development continuum to inform internal decisions and external regulatory interactions. + Creates or assists in the preparation of protocol… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Serve as clinical liaison to Global Device Team, including engineering, regulatory affairs , quality, and commercial functions + Coordinate interdepartmental ... deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** **Device Clinical Strategy & Risk Management:**… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and biomarker assay development and validation. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement ... issues to management as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase the external recognition of… more
- Oracle (Boston, MA)
- …workshops. Required Qualifications: + Professional licensure required, Registered Architect ( RA ) or Professional Engineer (PE). + Accredited degree in Architecture, ... Mechanical, Electrical, or Structural Engineering. + Strong preference for candidates with mechanical and liquid cooling design experience. + 8+ years of experience managing data center, mission-critical, or large-scale infrastructure design and development. +… more
- Veterans Affairs, Veterans Health Administration (Leeds, MA)
- …and other applicable laws, federal regulations, VA statutes and policy, and VHS & RA policy. Protects the data from unauthorized release or from loss, alteration, or ... influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Complete all application requirements detailed in… more